Clinical trial · Interventional
Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA
NCT00002568CI-TRIAL-00011246completedPhase 3ClinicalTrials.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 or combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136 PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging surgery
References
Publications (7)
- BACKGROUNDvon Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022. PMID 20471545
- BACKGROUNDFarley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482. PMID 19536873
- BACKGROUNDWinter WE 3rd, Maxwell GL, Tian C, Sundborg MJ, Rose GS, Rose PG, Rubin SC, Muggia F, McGuire WP; Gynecologic Oncology Group. Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2008 Jan 1;26(1):83-9. doi: 10.1200/JCO.2007.13.1953. Epub 2007 Nov 19. PMID 18025437
- BACKGROUNDWinter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517. PMID 17704411
- BACKGROUNDvan der Burg ME, Vergote I; Gynecological Cancer Group of the EORTC. The role of interval debulking surgery in ovarian cancer. Curr Oncol Rep. 2003 Nov;5(6):473-81. doi: 10.1007/s11912-003-0008-8. PMID 14521806
- RESULTWenzel L, Huang HQ, Monk BJ, Rose PG, Cella D. Quality-of-life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2005 Aug 20;23(24):5605-12. doi: 10.1200/JCO.2005.08.147. PMID 16110020