Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
This study has been completed.
Sponsor:
ARCAGY/ GINECO GROUP
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00189566
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011
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Purpose
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Malignant Tumor of Peritoneum |
Drug: Paclitaxel Drug: Topotecan Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse |
Resource links provided by NLM:
Further study details as provided by ARCAGY/ GINECO GROUP:
Primary Outcome Measures:
- Progression-free survival of patients in the three groups
Secondary Outcome Measures:
- Overall survival
- Rate of response and rate of progression at the end of treatment
- Qualitative and quantitative toxicities
- Quality of life
| Estimated Enrollment: | 165 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2009 |
The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged > 18
- Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
- Peritoneal and/or nodes and/or visceral metastases
- Disease in progression under treatment or within 6 months after a first or second platinum-based line
- A period of 3 weeks between last chemotherapy and inclusion
- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria)
- ECOG performance status < 2
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Previously received weekly administration of paclitaxel chemotherapy
- Involved in a trial within the last 30 days
- Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
- Prior diagnosis of malignancy
- History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy
- Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
- Bone marrow, renal, or hepatic insufficiency
- Severe active infection or occlusive or sub-occlusive disease
- History of symptomatic brain metastases
- Fertile women not using adequate contraceptive methods
- Pregnant or breast feeding women
- Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00189566 History of Changes |
| Other Study ID Numbers: | CAR\TAXHY |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 24, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by ARCAGY/ GINECO GROUP:
|
Relapse within 6 months Previously received taxane derivative |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Carboplatin Paclitaxel Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013