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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00807079
First received: December 10, 2008
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: carboplatin
Drug: topotecan hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Maximum tolerated dose of topotecan hydrochloride (Phase I) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Objective response rate (Phase II) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Drug: carboplatin Drug: topotecan hydrochloride

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807079

Locations
France
Hotel Dieu de Paris
Paris, France, 75181
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Laure Chauvenet, MD Hotel Dieu de Paris
  More Information

Additional Information:
No publications provided

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT00807079     History of Changes
Other Study ID Numbers: CDR0000626790, ARCAGY-GINECO-CE102, ARCAGY-HYCAR, INCA-RECF0757, EUDRACT-2008-001842-19
Study First Received: December 10, 2008
Last Updated: October 28, 2014
Health Authority: France: AFSSAPS

Keywords provided by ARCAGY/ GINECO GROUP:
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Carboplatin
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014