Trials / Completed
CompletedNCT00520013
Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors
A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell mullerian tumors respond to consolidation therapy with Avastin and erlotinib or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.
Detailed description
Objectives: Primary To examine the progression free survival (PFS) of Avastin and Erlotinib (AE) or Avastin (A) as consolidation therapy. Secondary To examine the toxicity between the two consolidative regimens AE vs. A. To assess the response rate of CTA. STATISTICAL DESIGN This study uses a randomized selection design. Both consolidation treatment arms are deemed experimental and are compared against a historical control \[McGuire WP et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. NEJM 1996: 334:1-6. PMID:7494563\]. With 30 patients in a given arm and 6 months of follow-up, there was 80% power to detect a 61.5% increase in median PFS from 13 months to 21 months assuming 1-sided 10% significance.
Conditions
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- Papillary Serous Mullerian Tumor
- Clear Cell Mullerian Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bevacizumab | |
| DRUG | erlotinib | |
| DRUG | paclitaxel | |
| DRUG | carboplatin |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-10-01
- Completion
- 2013-11-01
- First posted
- 2007-08-23
- Last updated
- 2018-07-27
- Results posted
- 2015-07-03
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00520013. Inclusion in this directory is not an endorsement.