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Completed

NCT Number: NCT00189566

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Malignant Tumor of Peritoneum Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Hotel Dieu

Paris, 75004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

Topotecan

Drug

carboplatin

Drug

Primary outcomes

  1. Progression-free survival of patients in the three groups

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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