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

NCT ID: NCT00520013

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

carboplatin/paclitaxel/bevacizumab then bevacizumab

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

erlotinib

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

carboplatin/paclitaxel/bevacizumab

Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation: None

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

Interventions

bevacizumab

Intervention Type: DRUG

erlotinib

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

Other Intervention Names

Avastin; rhuMAB VEGF; Tarceeva; Taxol; Paraplatin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Susana M. Campos, MD

Medical Oncologist.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana Campos, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

07-039

Identifier Type: -

Identifier Source: org_study_id