Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dana-Farber Cancer Institute
With
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
18 years of age and older
Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, primary peritoneal carcinoma, or papillary serous mullerian carcinoma
Previous attempted surgical debulking
Stage III or IV
Willing and able to undergo second look laparoscopy
Performance status 0-1 by ECOG scale
Peripheral neuropathy \< grade 2
Life expectancy of 6 months or greater
You may not be if
Patients with clinically significant cardiovascular disease as outlined in the protocol
Alkaline phosphatase or bilirubin \> 1.5 x ULN, SGOT \> 5 x ULN
Calculated creatinine clearance \< 50ml/min
Prior chemotherapy or radiotherapy for other malignancy except for the treatment for localized breast cancer greater than five years prior to diagnosis
No more than one cycle of first line chemotherapy with carboplatin and paclitaxel
Inadequate surgical cytoreduction such that interval cytoreductive surgery could materially improve prognosis
Concurrent invasive malignancy
Evidence of bleeding diathesis or coagulopathy
Evidence of tumor involving major blood vessels on any prior CT scans
Surgical wound that has failed to close
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of this study
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
Serious non-healing wound, ulcer, or bone fracture
Prior treatment with an anti-angiogenic agent
Any active bleeding
Active psychiatric disease or neurologic symptoms requiring treatment
Presence of central nervous system brain metastases
Proteinuria at screening as demonstrated by criteria in protocol
Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
Known hypersensitivity to Cremophor EL or any component of Avastin
Active bacterial, viral, or fungal infections
Receiving any other investigational agent
History of gastrointestinal perforation
Prior therapies targeting the epidermal growth factor receptor
Symptoms of bowel obstruction
Dependence on TPN or IV hydration
Clareo Health | 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
