Trial Outcomes & Findings for Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer (NCT NCT00087126)
NCT ID: NCT00087126
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
27 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Results posted on
2019-01-08
Participant Flow
This trial was opened to patient entry on January 3, 2005 and was closed to accrual on October 29, 2007.
Participant milestones
| Measure |
Topotecan Hydrochloride
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Topotecan Hydrochloride
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
|---|---|
|
Overall Study
Ineligible - second primary
|
1
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Topotecan Hydrochloride
n=25 Participants
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
|---|---|
|
Age, Customized
<40 years
|
4 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
10 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
8 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 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; every 6 months thereafter until disease progression for up to 5 years.Population: Eligible and treated patients with sufficient follow-up assessments to evaluate response
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 |
Topotecan Hydrochloride
n=22 Participants
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
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
Complete response
|
0 participants
|
—
|
—
|
—
|
—
|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Partial response
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-upPopulation: Eligible and treated patients
All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).
Outcome measures
| Measure |
Topotecan Hydrochloride
n=25 Participants
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
Grade 1 (CTCAE v 3.0)
n=25 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=25 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=25 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=25 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Leukopenia
|
6 participants
|
4 participants
|
9 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Thrombocytopenia
|
16 participants
|
4 participants
|
3 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neutropenia
|
9 participants
|
8 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Transfusions
|
24 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Anemia
|
1 participants
|
4 participants
|
12 participants
|
7 participants
|
1 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hemorrhage
|
24 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Nausea/Vomiting
|
13 participants
|
7 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Other gastrointestinal
|
12 participants
|
4 participants
|
6 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Genito urinary
|
22 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neurotoxicity
|
19 participants
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pain
|
19 participants
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pulmonary
|
24 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Infection
|
22 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Constitutional
|
8 participants
|
5 participants
|
7 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Metabolic
|
22 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Dermatologic
|
22 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Alopecia
|
17 participants
|
7 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Renal
|
21 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Alkaline Phosphatase
|
23 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vascular
|
24 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Lymphatics
|
24 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Lymphopenia
|
24 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Topotecan Hydrochloride
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topotecan Hydrochloride
n=25 participants at risk
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
|---|---|
|
General disorders
Fatigue
|
4.0%
1/25 • 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 (Not Otherwise Specified)
|
4.0%
1/25 • 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: Lung (Pneumonia)
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Central nervous system ischemia
|
4.0%
1/25 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Diplopia
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Stricture, Anastomotic, Genitourinary - Ureter
|
4.0%
1/25 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
8.0%
2/25 • 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 |
Topotecan Hydrochloride
n=25 participants at risk
Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days)
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
76.0%
19/25 • 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
|
36.0%
9/25 • 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
|
64.0%
16/25 • 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
Transfusions
|
4.0%
1/25 • 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
|
96.0%
24/25 • 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
|
4.0%
1/25 • 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
|
48.0%
12/25 • 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
|
52.0%
13/25 • 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
Genito urinary
|
12.0%
3/25 • 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
|
24.0%
6/25 • 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
|
24.0%
6/25 • 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
|
4.0%
1/25 • 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
|
12.0%
3/25 • 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
|
68.0%
17/25 • 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
|
12.0%
3/25 • 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
|
12.0%
3/25 • 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
|
32.0%
8/25 • 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
Renal
|
16.0%
4/25 • 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
|
8.0%
2/25 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Vascular
|
4.0%
1/25 • 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
|
4.0%
1/25 • 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
Lymphopenia
|
4.0%
1/25 • 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