Trial Outcomes & Findings for ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer (NCT NCT00309959)
NCT ID: NCT00309959
Last Updated: 2019-01-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months until disease progression for up to 5 years.
Results posted on
2019-01-08
Participant Flow
This trial was opened to patient entry on November 6, 2006 and was closed to accrual on February 1, 2011.
Participant milestones
| Measure |
ABI-007
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ABI-007
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Ineligible - no prior chemotherapy
|
2
|
Baseline Characteristics
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
ABI-007
n=35 Participants
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
<40 years
|
6 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
15 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 participants
n=5 Participants
|
|
Age, Customized
>70 yeats
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months until disease progression for up to 5 years.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
| Measure |
ABI-007
n=35 Participants
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
|---|---|---|---|---|---|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Partial response
|
10 participants
|
—
|
—
|
—
|
—
|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Complete response
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsAssessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-upOutcome measures
| Measure |
ABI-007
n=35 Participants
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=35 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 2 (CTCAE v 3.0)
n=35 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 3 (CTCAE v 3.0)
n=35 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
Grade 4 (CTCAE v 3.0)
n=35 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
|---|---|---|---|---|---|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Leukopenia
|
11 participants
|
10 participants
|
12 participants
|
3 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Thrombocytopenia
|
30 participants
|
4 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Neutropenia
|
20 participants
|
6 participants
|
6 participants
|
1 participants
|
2 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Anemia
|
3 participants
|
6 participants
|
22 participants
|
4 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Nausea/Vomiting
|
15 participants
|
11 participants
|
9 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Other gastrointestinal
|
13 participants
|
10 participants
|
10 participants
|
2 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Genitourinary
|
34 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Neurotoxicity
|
15 participants
|
11 participants
|
8 participants
|
1 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Pain
|
20 participants
|
9 participants
|
4 participants
|
2 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Pulmonary
|
31 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Cardiovascular
|
34 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Fatigue
|
8 participants
|
7 participants
|
15 participants
|
5 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Metabolic
|
24 participants
|
5 participants
|
2 participants
|
4 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Dermatologic
|
30 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Alopecia
|
17 participants
|
3 participants
|
15 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Musculoskeletal
|
32 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Auditory
|
34 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Infection
|
27 participants
|
0 participants
|
4 participants
|
4 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
SGOT
|
34 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Alkaline phosphatase
|
34 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Lymphatics
|
31 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
ABI-007
Serious events: 17 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABI-007
n=35 participants at risk
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
General disorders
Fever
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death No Ctcae Term - Death Nos
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Prolapse Of Stoma, Gi
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Infection with Normal Or Grade 1 Or 2 Absolute Neutrophil Count: Blood
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
5.7%
2/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neurology - Other
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Back
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Cystitis
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Other adverse events
| Measure |
ABI-007
n=35 participants at risk
ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
71.4%
25/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
5/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
15/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Anemia
|
91.4%
32/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea/vomiting
|
57.1%
20/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Other gastrointestinal
|
62.9%
22/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
GU
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neurotoxicity
|
57.1%
20/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain
|
42.9%
15/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
14.3%
5/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Cardiovascular
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Constitutional (Fatigue)
|
77.1%
27/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Metabolic
|
31.4%
11/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
14.3%
5/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.4%
18/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
8.6%
3/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Auditory
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Infection
|
22.9%
8/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
SGOT
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Alkaline phosphatase
|
2.9%
1/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Lymphatics
|
11.4%
4/35 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60