Clinical trial · Interventional
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
- 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. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carboplatin, paclitaxel, low dose paclitaxel
- description
- carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Carboplatin, paclitaxel
- description
- carboplatin, paclitaxel
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (3)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types: * Serous adenocarcinoma * Malignant Brenner's tumor * Mucinous adenocarcinoma * Endometrioid * Adenocarcinoma * Clear cell adenocarcinoma * Undifferentiated carcinoma * Transitional cell * Mixed epithelial carcinoma * Adenocarcinoma - not otherwise specified * Meets 1 of the following criteria: * Stage Ia or Ib, grade 3 or clear cell * Stage Ic or II, all grades/histologies * Complete surgical staging * No tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-3 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * Alkaline phosphatase no greater than 3 times normal * SGOT no greater than 3 times normal Renal: * Creatinine no greater than 2.0 mg/dL Other: * No other invasive malignancies within the past 5 years except nonmelanoma skin cancer * No major systemic medical illness expected to affect survival * Body surface area no greater than 2.0 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No prior treatment for this malignancy except surgical staging * No prior anticancer therapy that would preclude study participation
References
Publications (1)
- RESULTMannel RS, Brady MF, Kohn EC, Hanjani P, Hiura M, Lee R, Degeest K, Cohn DE, Monk BJ, Michael H. A randomized phase III trial of IV carboplatin and paclitaxel x 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2011 Jul;122(1):89-94. doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6. PMID 21529904