Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer - Full Text View

Sponsored by:	Association de Recherche sur les Cancers dont Gynecologiques at Hopital de l'Hotel Dieu
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00807079

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 I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose of topotecan hydrochloride (Phase I) [ Designated as safety issue: Yes ]
Objective response rate (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	September 2008
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

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

Locations

France
Hotel Dieu de Paris	Recruiting
Paris, France, 75181
Contact: Laure Chauvenet, MD 33-1-42-348-413

Sponsors and Collaborators

Association de Recherche sur les Cancers dont Gynecologiques at Hopital de l'Hotel Dieu

Investigators

Investigator:

Laure Chauvenet, MD

Hotel Dieu de Paris

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000626790, ARCAGY-GINECO-CE102, ARCAGY-HYCAR, INCA-RECF0757, EUDRACT-2008-001842-19
Study First Received:	December 10, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00807079
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer

cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Carcinoma, squamous cell
Carboplatin
Topotecan

Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Recurrence
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009