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:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00189566
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011
  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
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189566

Locations
France
Hôpital Hotel Dieu
Paris, France, 75004
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Study Director: Laure Chauvenet, MD, PhD Hôpital Hôtel Dieu
  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 July 28, 2014