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

NCT00520013 | Completed Phase 2 Results DMC

• 1 other identifier: 07-039
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Papillary Serous Mullerian Tumor; Clear Cell Mullerian Tumor

Outcome Measures

Primary Outcomes (2)

• Consolidation Progression-Free Survival

  Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to \>/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.

  Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.

• Consolidation Treatment-related Toxicity Rate

  Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.

  Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.

Secondary Outcomes (1)

• Consolidation Objective Response Rate

  Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.

Study Arms (3)

carboplatin/paclitaxel/bevacizumab then bevacizumab

EXPERIMENTAL

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.

Drug: bevacizumab; Drug: paclitaxel; Drug: carboplatin

carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

EXPERIMENTAL

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.

Drug: bevacizumab; Drug: erlotinib; Drug: paclitaxel; Drug: carboplatin

carboplatin/paclitaxel/bevacizumab

EXPERIMENTAL

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

Drug: bevacizumab; Drug: paclitaxel; Drug: carboplatin

Interventions

bevacizumab DRUG

Also known as: Avastin, rhuMAB VEGF

carboplatin/paclitaxel/bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

erlotinib DRUG

Also known as: Tarceeva

carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

paclitaxel DRUG

Also known as: Taxol

carboplatin/paclitaxel/bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

carboplatin DRUG

Also known as: Paraplatin

carboplatin/paclitaxel/bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab; carboplatin/paclitaxel/bevacizumab then bevacizumab/erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Susana M. Campos, MD, MPH
• Organization: Dana-Farber Cancer Institute

susana_campos@dfci.harvard.edu

617-632-5269

Study Officials

• Susana Campos, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist.

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 23, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2013
• Last Updated: July 27, 2018
• Results First Posted: July 3, 2015

Record last verified: 2018-07

Locations

US (3)