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A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 2008-08 |
| Completion | 2010-10 |
Conditions
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
Interventions
- doxorubicin HCL liposome; bevacizumab; carboplatin
Primary outcomes
- The Primary Efficacy End Point is the Number of Patients With an Objective Response. — Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Countries
United States