Phase 2
N=27
Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00087126 ↗Enrolled (actual)
27
Serious AEs
36.0%
Results posted
Jan 2019
Primary outcome: Primary: Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- topotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 |
0; 0 | — |
| PRIMARY Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 |
6; 4; 9; 5; 1; 16 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the cervix
- Squamous cell or nonsquamous cell
- Persistent or recurrent disease
- Documented disease progression
- Measurable disease
- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy
- Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix
- Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Sensory or motor neuropathy ≤ grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
- At least 3 weeks since prior biologic or immunologic agents for cervical cancer
- No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
- No concurrent prophylactic thrombopoietic agents
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
- No prior topotecan
Endocrine therapy
- At least 1 week since prior hormonal therapy for cervical cancer
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for cervical cancer
- No prior cancer therapy that would preclude study participation
Data sourced from ClinicalTrials.gov (NCT00087126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.