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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189566

Enrollment

165

Registered

2005-09-19

Start date

2004-04-30

Completion date

2009-04-30

Last updated

2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Malignant Tumor of Peritoneum, Ovarian Cancer

Keywords

Relapse within 6 months, Previously received taxane derivative

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.

Interventions

DRUGPaclitaxel

DRUGTopotecan

DRUGCarboplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival of patients in the three groups	—

Secondary

Measure	Time frame
Overall survival	—
Rate of response and rate of progression at the end of treatment	—
Qualitative and quantitative toxicities	—
Quality of life	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026