Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189566
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 25, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Malignant Tumor of Peritoneum Drug: Paclitaxel Drug: Topotecan Drug: Carboplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2004
Actual Study Completion Date : April 2009

Primary Outcome Measures :
  1. Progression-free survival of patients in the three groups

Secondary Outcome Measures :
  1. Overall survival
  2. Rate of response and rate of progression at the end of treatment
  3. Qualitative and quantitative toxicities
  4. Quality of life

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189566

Hôpital Hotel Dieu
Paris, France, 75004
Sponsors and Collaborators
Study Director: Laure Chauvenet, MD, PhD Hôpital Hôtel Dieu Identifier: NCT00189566     History of Changes
Other Study ID Numbers: CAR\TAXHY
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Keywords provided by ARCAGY/ GINECO GROUP:
Relapse within 6 months
Previously received taxane derivative

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Disease Attributes
Pathologic Processes
Fallopian Tube Diseases
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators