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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189566
• Other study ID #: CAR\TAXHY
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 24, 2011
• Start date: April 2004
• Est. completion date: April 2009

Study information

• Verified date: February 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Malignant Tumor of Peritoneum
• Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• Paclitaxel

• Topotecan

• Carboplatin

Locations

Country	Name	City	State
France	Hôpital Hotel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival of patients in the three groups
Secondary	Overall survival
Secondary	Rate of response and rate of progression at the end of treatment
Secondary	Qualitative and quantitative toxicities
Secondary	Quality of life