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

NCT00807079 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000626790ARCAGY-GINECO-CE102ARCAGY-HYCARINCA-RECF0757EUDRACT-2008-001842-19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer; stage IVB cervical cancer; stage IVA cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of topotecan hydrochloride (Phase I)

  3 months

• Objective response rate (Phase II)

  3 months

Study Arms (1)

single arm

EXPERIMENTAL

Drug: carboplatin; Drug: topotecan hydrochloride

Interventions

carboplatin DRUG

single arm

topotecan hydrochloride DRUG

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (1)

Hotel Dieu de Paris

Paris, 75181, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Carboplatin; Topotecan

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Laure Chauvenet, MD

  Hotel Dieu de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

FR (1)