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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Papillary Serous Mullerian Tumor, Clear Cell Mullerian Tumor

In brief

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.

Key facts

Study ID

NCT00520013

Run by

Dana-Farber Cancer Institute

People needed

60

Starts

2007-08-01

Expected to finish

2013-11-01

Last updated by the study team

2018-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

• Patients with clinically significant cardiovascular disease as outlined in the protocol
• Neutrophil count < 1,500/mm3; platelet count <100,000/m3
• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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