Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cervical Cancer

Treatments

Drug: carboplatin

Drug: topotecan hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00807079

ARCAGY-HYCAR

INCA-RECF0757

EUDRACT-2008-001842-19

CDR0000626790

ARCAGY-GINECO-CE102

Details and patient eligibility

About

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with carboplatin and to see how well they work in treating patients with relapsed or metastatic cervical cancer.

Full 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 determine the objective response rate in patients treated with this regimen. (Phase II)

Secondary

To determine the dose-limiting toxicities of this regimen in these patients. (Phase I)
To assess the progression-free survival of patients treated with this regimen. (Phase II)
To assess the overall survival of patients treated with this regimen. (Phase II)
To assess the tolerability of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study of topotecan hydrochloride followed by a phase II study.

Patients receive oral topotecan hydrochloride on days 1, 8, and 15 and carboplatin IV on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete a quality-of-life questionnaire at baseline and then every 3 months thereafter.

After completion of study therapy, patients are followed every 3 months for 1 year.

Enrollment

12 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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