Trial Outcomes & Findings for Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus (NCT NCT00025506)

Last Updated: 2019-07-24

Results Overview

Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Every other cycle for 6 months

Results posted on

2019-07-24

Participant Flow

The study was activated on 9/4/2001 and closed to accrual on 3/3/2008 (suspended from 6/30/2003 to 8/1/2005).

Participant milestones

Participant milestones
Measure	Thalidomide Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Study STARTED	55
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Thalidomide Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Overall Study Ineligible: clerical error	1
Overall Study Ineligible: wrong cell type	5
Overall Study Ineligible: inadequate pathology	2
Overall Study Never Treated	2

Baseline Characteristics

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Age, Continuous	65.6 years STANDARD_DEVIATION 8.9 • n=5 Participants
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	1 participants n=5 Participants
Age, Customized 50-59 years	7 participants n=5 Participants
Age, Customized 60-69 years	23 participants n=5 Participants
Age, Customized 70-79 years	11 participants n=5 Participants
Age, Customized 80-89 years	2 participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Histologic type Carcinosarcoma-homologous	22 participants n=5 Participants
Histologic type Carcinosarcoma-heterologous	16 participants n=5 Participants
Histologic type Carcinosarcoma, MMT	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Every other cycle for 6 months

Population: Eligible and treated patients.

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Progression-free Survival (PFS) > 6 Months	17.8 percentage of participants Interval 9.0 to 30.0	—	—	—	—

PRIMARY outcome

Timeframe: Each cycle during treatment and 30 days after the last treatment (average 4 months)

Population: Eligible and evaluable patients

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 n=45 Participants Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 n=45 Participants Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 n=45 Participants Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 n=45 Participants Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Nausea	31 Participants	4 Participants	6 Participants	4 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Vomiting	36 Participants	4 Participants	4 Participants	1 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Constipation	27 Participants	6 Participants	9 Participants	3 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Anorexia	42 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Fatigue	22 Participants	5 Participants	15 Participants	3 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Neutropenia	41 Participants	1 Participants	3 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Thrombocytopenia	44 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Anemia	22 Participants	9 Participants	9 Participants	4 Participants	1 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Cardiovascular	31 Participants	9 Participants	2 Participants	1 Participants	2 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Neuropathy (sensory)	27 Participants	12 Participants	5 Participants	1 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Other neurologic	31 Participants	2 Participants	6 Participants	6 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Dermatologic	39 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Metabolic	40 Participants	3 Participants	0 Participants	2 Participants	0 Participants
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0 Pain	38 Participants	4 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Every other cycle until progression or death, up to 5 years.

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Progression Free Survival	1.91 months Interval 1.35 to 4.17	—	—	—	—

SECONDARY outcome

Timeframe: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)

Population: Eligible and treated patients.

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Tumor Response	4.4 percentage of participants Interval 1.0 to 13.0	—	—	—	—

SECONDARY outcome

Timeframe: From study entry to death or last contact, up to 5 years.

Population: Eligible and treated patients.

The observed length of life from entry into the study to death or the date of last contact.

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Overall Survival	5.9 months Interval 3.6 to 9.6	—	—	—	—

SECONDARY outcome

Timeframe: baseline

Population: Eligible and evaluable patients

Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work. Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Initial Performance Status Performance status = 0	30 Participants	—	—	—	—
Initial Performance Status Performance status = 1	12 Participants	—	—	—	—
Initial Performance Status Performance status = 2	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Eligible and evaluable patients

G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.

Outcome measures

Outcome measures
Measure	Thalidomide n=45 Participants Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.	Grade 1 Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)	Grade 2 Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)	Grade 3 Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)	Grade 4 Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
Initial Histologic Grade Grade 3	4 Participants	—	—	—	—
Initial Histologic Grade Not graded	41 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Thalidomide

Serious events: 15 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Thalidomide n=45 participants at risk Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Cardiac disorders Thrombosis Embolism	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Constitutional Symptoms Other	11.1% 5/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Constipation	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dehydration	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Nausea	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gi Other	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Hemorrhage With Grade 3/4 Thrombocytopenia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Bilirubin	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.

Other adverse events

Other adverse events
Measure	Thalidomide n=45 participants at risk Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
Ear and labyrinth disorders Inner Ear/Hearing	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Neutropenia	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Thrombocytopenia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Lymphopenia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Leukopenia	13.3% 6/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Transfusion Prbc's	15.6% 7/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Anemia	64.4% 29/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Transfusion Platelets	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Arrhythmia Nodal/Junctional Dysrhythmia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Edema	26.7% 12/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Thrombosis Embolism	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Palpitations	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Fever(No Neutropenia)	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Weight Gain(No Vod)	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Constitutional Symptoms Other	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Sweating	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Fatigue	53.3% 24/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Alopecia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Rash Desquamation	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Bruising	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Dry Skin	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Endocrine disorders Hot Flashes/Flushes	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Anorexia	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Flatulence	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Diarrhea With Colostomy	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Mouth Dryness	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Ascites Non-Malignant	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Taste Disturbance	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Diarrhea Without Colostomy	13.3% 6/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Constipation	44.4% 20/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Stomatitis/Pharyngitis	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dehydration	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Vomiting	26.7% 12/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Nausea	35.6% 16/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gi Other	11.1% 5/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Rectal Bleeding/Hematochezia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Epistaxis	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Vaginal Bleeding	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Hematuria No Vaginal Bleeding	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Hepatic Other	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Hypoalbuminemia	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Sgot(Ast)	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Alkaline Phosphatase	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Hepatobiliary disorders Bilirubin	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Infections and infestations Infection Without Neutropenia	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Blood and lymphatic system disorders Lymphatics	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Metabolic Other	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyponatremia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypernatremia	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypocalcemia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypermagnesemia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyperglycemia	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypokalemia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypomagnesmia	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Muscle Weakness	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Tremor	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Hallucinations	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Depressed Level Of Consciousness	17.8% 8/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Cognitive Disturbance	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Ataxia(Incoordination)	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Mood Alteration Anxiety/Agitation	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Insomnia	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Dizziness	15.6% 7/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Mood Alteration Depression	6.7% 3/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Neuropathy Sensor	42.2% 19/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Eye disorders Ocular Other	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Eye disorders Dry Eye	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Eye disorders Vision Flashing Lights/Floaters	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Eye disorders Vision Blurred	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Abdominal Pain	15.6% 7/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Pain Other	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Pain Tumor	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Headache	13.3% 6/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Pelvic Pain	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Chest Pain	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Bone Pain	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Arthralgia	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Myalgia	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Pain Rectal/Perirectal	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Other	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis/Pulmonary Infiltrates	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	24.4% 11/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Frequency/Urgency	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Creatinine	8.9% 4/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Renal/Gu Other	4.4% 2/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Vaginitis No Infection	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Retention	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Ureteral Obstruction	2.2% 1/45 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.

Additional Information

Angela M. Kuras, Associate Director of Data Management

NRG Oncology Statistics and Data Management Center - Buffalo

Phone: 716-845-7733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60