Phase 3
Completed N=571
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
Source: ClinicalTrials.gov NCT00003644 ↗Enrolled (actual)
571
Serious AEs
2.2%
Results posted
Apr 2019
Primary outcomePrimary: Progression-free Survival — 20.4; 23.2 percentage of participants
◆ Published Evidence
Established
69citations · ~5 / year
A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study.
Summary
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.
Linked Publications
-
A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
20.4; 23.2 | — |
| PRIMARY Overall Survival |
44; 53 | — |
| PRIMARY Number of Participants With Adverse Events Grade 3 or Greater |
74; 86; 12; 16; 203; 196 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00003644) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.