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
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Papillary Serous Mullerian Tumor; Clear Cell Mullerian Tumor
MeSH terms: Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Mixed Tumor, Mullerian
Intervention: bevacizumab; erlotinib; paclitaxel; carboplatin
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

          -  Prior therapies targeting the epidermal growth factor receptor

          -  Symptoms of bowel obstruction

          -  Dependence on TPN or IV hydration