Clinical trial · Interventional
Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
NCT00004081CI-TRIAL-00007820completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy * Platinum resistance as defined by one of the following: * Relapse within 6 months of platinum based chemotherapy * Residual disease after completion of platinum based chemotherapy * Disease progression while receiving platinum based chemotherapy * Marker only relapse (CA-125 elevation) and measurable disease * Bidimensionally measurable disease on exam or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Performance status: * ECOG 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * WBC at least 3,000/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGPT or SGOT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * Acceptable cardiac exam * No active cardiac ischemia Pulmonary: * Acceptable pulmonary exam * No active pulmonary infection or compromise Other: * Not pregnant or nursing * No severe peripheral neuropathy (grade 2 or greater) * No other significant psychiatric or medical conditions that would interfere with compliance * No other malignancies within the past 3 years, except: * Limited basal or squamous cell skin cancer * Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior cytokine therapy Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer * Prior paclitaxel allowed * No prior docetaxel * At least 3 years since prior chemotherapy for other disease Endocrine therapy: * Not specified Radiotherapy: * No prior pelvic radiotherapy Surgery: * Not specified
References
Publications (1)
- RESULTBerkenblit A, Seiden MV, Matulonis UA, Penson RT, Krasner CN, Roche M, Mezzetti L, Atkinson T, Cannistra SA. A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer. Gynecol Oncol. 2004 Dec;95(3):624-31. doi: 10.1016/j.ygyno.2004.08.028. PMID 15581974