Trial Outcomes & Findings for Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer (NCT NCT00548418)
NCT ID: NCT00548418
Last Updated: 2014-08-01
Results Overview
Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Progression-free survival at 6 months
Results posted on
2014-08-01
Participant Flow
Enrollment to the study opened to participants on 02/20/07 and enrollment to the study was closed to participants on 11/07/11.
Participant milestones
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=27 Participants
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 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
|
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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Performance status
0
|
14 participants
n=5 Participants
|
|
Performance status
1
|
13 participants
n=5 Participants
|
|
Disease stage
I
|
9 participants
n=5 Participants
|
|
Disease stage
II
|
8 participants
n=5 Participants
|
|
Disease stage
III
|
8 participants
n=5 Participants
|
|
Disease stage
IV
|
2 participants
n=5 Participants
|
|
Histologic type
Squamous cell
|
18 participants
n=5 Participants
|
|
Histologic type
Adenocarcinoma
|
9 participants
n=5 Participants
|
|
Grade
1
|
2 participants
n=5 Participants
|
|
Grade
2
|
11 participants
n=5 Participants
|
|
Grade
3
|
14 participants
n=5 Participants
|
|
Prior hysterectomy
No
|
22 participants
n=5 Participants
|
|
Prior hysterectomy
Yes
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Progression-free survival at 6 monthsDefined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.
Outcome measures
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=27 Participants
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Anti-tumor Activity as Measured by Surviving Progression-free
|
59 percentage of participants
|
SECONDARY outcome
Timeframe: Until death (follow-up ranged from 1.7 months to 33.4 months)Defined as time from study entry until death from any cause or date of last contaqct.
Outcome measures
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=27 Participants
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Overall Survival
|
13.2 months
An 80% confidence interval was calculated and ranged from 8 to 15.4.
|
SECONDARY outcome
Timeframe: Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)Population: 26 participants were evaluable for response.
RECIST criteria: Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response is 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. Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, 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, progression of existing non-target lesions Stable disease is any condition not meeting the above criteria
Outcome measures
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=26 Participants
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Frequency of Response as Measured by RECIST Criteria (Imaging)
Complete response
|
1 participants
|
|
Frequency of Response as Measured by RECIST Criteria (Imaging)
Partial response
|
8 participants
|
|
Frequency of Response as Measured by RECIST Criteria (Imaging)
Stable disease
|
10 participants
|
|
Frequency of Response as Measured by RECIST Criteria (Imaging)
Progressive disease
|
7 participants
|
SECONDARY outcome
Timeframe: Correlative studies when specimens availablePopulation: None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: When specimens availablePopulation: None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Cisplatin, Topotecan, Bevacizumab)
Serious events: 12 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=27 participants at risk
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Gastrointestinal disorders
Esophageal stenosis
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Investigations
Elevated creatinine
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Vascular disorders
Blood clot/DVT
|
7.4%
2/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Infections and infestations
Infection - catheter
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Injury, poisoning and procedural complications
Bone fracture
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
General disorders
Fever
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Cardiac disorders
Sudden cardiovascular collapse
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
Other adverse events
| Measure |
Treatment (Cisplatin, Topotecan, Bevacizumab)
n=27 participants at risk
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
|
|---|---|
|
Investigations
Leukopenia
|
92.6%
25/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Investigations
Neutropenia
|
77.8%
21/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Investigations
Thrombocytopenia
|
96.3%
26/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
27/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Immune system disorders
Allergy
|
11.1%
3/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Ear and labyrinth disorders
Auditory
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Cardiac disorders
Cardiovascular
|
55.6%
15/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Investigations
Coagulation
|
33.3%
9/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Investigations
Constitutional
|
96.3%
26/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
51.9%
14/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Endocrine disorders
Endocrine
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal
|
96.3%
26/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Renal and urinary disorders
Genitourinary/renal
|
48.1%
13/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Vascular disorders
Hemorrhage
|
22.2%
6/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Infections and infestations
Infection
|
44.4%
12/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Blood and lymphatic system disorders
Lymphatic
|
25.9%
7/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Metabolism and nutrition disorders
Metabolic
|
96.3%
26/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
11.1%
3/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Nervous system disorders
Neurologic
|
55.6%
15/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Eye disorders
Visual
|
3.7%
1/27 • From the start of treatment through 30 days following the end of treatment.
|
|
General disorders
Pain
|
88.9%
24/27 • From the start of treatment through 30 days following the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
40.7%
11/27 • From the start of treatment through 30 days following the end of treatment.
|
Additional Information
David G. Mutch, M.D.
Washington University School of Medicine
Phone: 314-362-2181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place