Status:
COMPLETED
Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of topotecan hydrochloride when administered with carboplatin in patients with relapsed or metastatic cervical cancer. (Phase I) * To de...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed cervical cancer, including the following cell types:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Metastatic disease or in first relapse
- Not curable by surgery and/or radiotherapy with or without chemotherapy
- At least 1 non-irradiated measurable lesion
- No CNS metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Transaminases ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other cancer within the past 5 years except for adequately treated basal cell or squamous cell carcinoma of the skin
- No swallowing disorders or gastrointestinal disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No altered intestinal absorption
- No peptic ulcers
- No nephrostomy
- Double-J catheter allowed
- None of the following cardiovascular conditions within the past 6 months:
- Uncontrolled hypertension
- Coronary artery disease
- NYHA class III or IV congestive heart failure
- Ventricular arrhythmia
- Unstable angina
- Myocardial infarction
- No infection or serious illness that would preclude study treatment
- No contraindications to study treatment
- No psychological, familial, sociological, or geographical condition that would preclude follow-up
- PRIOR CONCURRENT THERAPY:
- No prior cytotoxic therapy except for chemoradiotherapy or pelvic radiotherapy
- At least 6 months since prior platinum-based chemoradiotherapy
- No concurrent participation in another clinical trial that could interfere with the objectives of this study
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00807079
Start Date
September 1 2008
Last Update
October 29 2014
Active Locations (1)
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1
Hotel Dieu de Paris
Paris, France, 75181