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

NCT00189566 | Completed Phase 2

• 1 other identifier: CAR\TAXHY
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Malignant Tumor of Peritoneum

Keywords

Relapse within 6 months; Previously received taxane derivative

Outcome Measures

Primary Outcomes (1)

• Progression-free survival of patients in the three groups

Secondary Outcomes (4)

• Overall survival

• Rate of response and rate of progression at the end of treatment

• Qualitative and quantitative toxicities

• Quality of life

Interventions

Paclitaxel DRUG

Topotecan DRUG

Carboplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (1)

Hôpital Hotel Dieu

Paris, 75004, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Paclitaxel; Topotecan; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes

Study Officials

• Laure Chauvenet, MD, PhD

  Hôpital Hôtel Dieu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2004
• Study Completion: April 1, 2009
• Last Updated: February 25, 2011

Record last verified: 2011-02

Locations

FR (1)