Trial Outcomes & Findings for Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer (NCT NCT01671332)

Last Updated: 2020-05-12

Results Overview

Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2020-05-12

Participant Flow

Recruitment occurred from June 2012 through April 2014.

Participant milestones

Participant milestones
Measure	Docetaxel Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Overall Study STARTED	40	40
Overall Study Crossed Over to Docetaxel Plus Suramin	0	13
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel n=40 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=40 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2	Total n=80 Participants Total of all reporting groups
Age, Customized 18-39 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 40-49 years	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Age, Customized 50-59 years	18 participants n=5 Participants	11 participants n=7 Participants	29 participants n=5 Participants
Age, Customized 60-69 years	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Age, Customized 70-79 years	3 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants
Age, Customized 80-89 years	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized White, Not of Hispanic Origin	38 participants n=5 Participants	35 participants n=7 Participants	73 participants n=5 Participants
Race/Ethnicity, Customized Black or African American, Not of Hispanic Origin	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.

Outcome measures

Outcome measures
Measure	Docetaxel n=40 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=40 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Progression-free Survival in Months	2.8 months Interval 0.9 to 4.2	1.6 months Interval 1.4 to 2.1

SECONDARY outcome

Timeframe: Up to 1 year

Population: The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.

Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD

Outcome measures

Outcome measures
Measure	Docetaxel n=40 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=40 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Response Rate Per RECIST 1.1 Criteria Partial Response	1 participants	3 participants
Response Rate Per RECIST 1.1 Criteria Stable Disease	17 participants	11 participants
Response Rate Per RECIST 1.1 Criteria Progressive Disease	17 participants	25 participants
Response Rate Per RECIST 1.1 Criteria Not Assessed	5 participants	1 participants

SECONDARY outcome

Timeframe: Up to 50 months

Population: The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.

Compare overall survival of participants in both treatment arms.

Outcome measures

Outcome measures
Measure	Docetaxel n=40 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=40 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Overall Survival	5.3 months Interval 5.0 to 8.0	4.1 months Interval 3.2 to 7.6

SECONDARY outcome

Timeframe: Up to 2 years

Population: The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.

The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.

Outcome measures

Outcome measures
Measure	Docetaxel n=40 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=40 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Number of Participants With Toxicity/Adverse Events From Treatment	35 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline

Population: All participants who yielded good quality PBL samples were included.

The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.

Outcome measures

Outcome measures
Measure	Docetaxel n=18 Participants Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=28 Participants Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.	0.91 G2-M checkpoint control score Standard Deviation 0.37	1.30 G2-M checkpoint control score Standard Deviation 0.89

Adverse Events

Docetaxel

Serious events: 19 serious events

Other events: 39 other events

Deaths: 40 deaths

Docetaxel Plus Suramin

Serious events: 26 serious events

Other events: 49 other events

Deaths: 37 deaths

Serious adverse events

Other adverse events

Additional Information

Anne Traynor

University of Wisconsin

Phone: 608-262-5092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Docetaxel n=40 participants at risk Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.	Docetaxel Plus Suramin n=53 participants at risk Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Immune system disorders Anaphylaxis	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Blood and lymphatic system disorders Anemia	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	5.7% 3/53 • Number of events 3 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Psychiatric disorders Anxiety	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Investigations Aspartate aminotransferase increased	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Cardiac disorders Atrial fibrillation	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	7.5% 4/53 • Number of events 4 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Infections and infestations Catheter related infection	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Cardiac disorders Chest pain	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Colitis	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Psychiatric disorders Confusion	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Constipation	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
General disorders Death NOS	7.5% 3/40 • Number of events 3 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	9.4% 5/53 • Number of events 5 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Metabolism and nutrition disorders Dehydration	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Nervous system disorders Dizziness	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Dysphagia	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	9.4% 5/53 • Number of events 5 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Esophageal obstruction	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
General disorders Fatigue	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Cardiac disorders Febrile neutropenia	5.0% 2/40 • Number of events 3 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
General disorders Gait disturbance	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Nervous system disorders Headache	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Vascular disorders Hypertension	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	5.7% 3/53 • Number of events 3 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Vascular disorders Hypotension	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	5.7% 3/53 • Number of events 3 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Investigations INR increased	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Nervous system disorders Intracranial hemorrhage	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Infections and infestations Lung infection	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	3.8% 2/53 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
General disorders Multi-organ failure	5.0% 2/40 • Number of events 2 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	0.00% 0/53 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 1/40 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Cardiac disorders Myocardial infarction	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
Gastrointestinal disorders Nausea	0.00% 0/40 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.	1.9% 1/53 • Number of events 1 • Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days. AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.