Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Previously Untreated Stage III or Stage IV Ovarian or Primary Peritoneal Cancer
A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma
NCT00003378CI-TRIAL-00011233terminatedPhase 1ClinicalTrials.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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage IV ovarian or primary peritoneal cancer.
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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated: Stage III or stage IV ovarian epithelial cancer Stage III or stage IV primary peritoneal cancer PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Effective contraception required of fertile patients No significant infections No other severe medical problems that would subject patient to undue risk from this protocol No other active malignancy within past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this or any other malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for this or any other malignancy Surgery: No prior surgery other than cytoreductive surgery and recovered
References
Publications (2)
- RESULTGould N, Sill MW, Mannel RS, Thaker PH, Disilvestro P, Waggoner S, Yamada SD, Armstrong DK, Wenzel L, Huang H, Fracasso PM, Walker JL. A phase I study with an expanded cohort to assess the feasibility of intravenous paclitaxel, intraperitoneal carboplatin and intraperitoneal paclitaxel in patients with untreated ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Apr;125(1):54-8. doi: 10.1016/j.ygyno.2011.12.417. Epub 2011 Dec 11. PMID 22155262
- RESULTLook KY, Bookman MA, Schol J, Herzog TJ, Rocereto T, Vinters J; Gynecologic Oncology Group Study. Phase I feasibility trial of carboplatin, paclitaxel, and gemcitabine in patients with previously untreated epithelial ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):93-100. doi: 10.1016/j.ygyno.2003.09.019. PMID 14751144