Clinical trial NCT00189566: Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Malignant Tumor of Peritoneum
Keywords: Relapse within 6 months
Previously received taxane derivative
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Progression-free survival of patients in the three groups
Secondary outcomes:
measure: Overall survival
measure: Rate of response and rate of progression at the end of treatment
measure: Qualitative and quantitative toxicities
measure: Quality of life
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hotel Dieu
Study officials:
affiliation: Hôpital Hôtel Dieu
name: Laure Chauvenet, MD, PhD
role: STUDY_DIRECTOR
References: