search
Back to results

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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
carboplatin
topotecan hydrochloride
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu de Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose of topotecan hydrochloride (Phase I)
Objective response rate (Phase II)

Secondary Outcome Measures

Full Information

First Posted
December 10, 2008
Last Updated
October 28, 2014
Sponsor
ARCAGY/ GINECO GROUP
search

1. Study Identification

Unique Protocol Identification Number
NCT00807079
Brief Title
Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer
Official Title
Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Primary Outcome Measure Information:
Title
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Time Frame
3 months
Title
Objective response rate (Phase II)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Chauvenet, MD
Organizational Affiliation
Hotel Dieu de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs