At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma
- ✓Platinum-sensitive disease: complete response to front-line platinum treatment with treatment-free interval >6 months without clinical evidence of progressive disease
- ✓Exactly one prior chemotherapy regimen for this malignancy; prior paclitaxel and/or platinum allowed; prior Taxotere® not allowed
- ✓Measurable or evaluable disease by imaging, physical exam, or CA125 <70 on two occasions at least one week apart
- ✕Prior treatment with Taxotere® (docetaxel)
- ✕Concurrent immunotherapy or hormonal therapy for disease treatment (must be discontinued at least one week prior)
- ✕Serious concurrent medical or psychiatric illness, including serious active infection
- ✕Peripheral neuropathy >grade 2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer
In Brief
A Phase 2 clinical trial evaluating Docetaxel and Carboplatin for Ovarian Cancer. Completed, enrolled 150 participants across 19 sites.
Detailed Summary
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
Study Details
Timeline
Interventions
For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin
Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel. Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel