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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807079
• Other study ID #: CDR0000626790
• Secondary ID: ARCAGY-GINECO-CE
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 10, 2008
• Last updated: October 28, 2014
• Start date: September 2008

Study information

• Verified date: October 2014
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• carboplatin

• topotecan hydrochloride

Locations

Country	Name	City	State
France	Hotel Dieu de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of topotecan hydrochloride (Phase I)		3 months	Yes
Primary	Objective response rate (Phase II)		3 months	No