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Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of topotecan hydrochloride (Phase I)

Safety Issue:

Yes

Principal Investigator

Laure Chauvenet, MD

Investigator Affiliation:

Hotel Dieu de Paris

Authority:

United States: Federal Government

Study ID:

CDR0000626790

NCT ID:

NCT00807079

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms

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