Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

NCT00126542 | Completed Phase 2

• 10 other identifiers: NCI-2012-02660UCCRC-13576ANCI-6759CDR000043482013576A6759N01CM62209P30CA014599N01CM62201N01CM62203
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.

Conditions

Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate of patients treated with the combination of bevacizumab and OSI-774

  Up to 5 years

Secondary Outcomes (3)

• Progression-free survival

  Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years

• Median progression-free survival

  From start of treatment to time of progression, assessed up to 5 years

• Overall survival

  Up to 5 years

Study Arms (1)

Treatment (bevacizumab, erlotinib hydrochloride)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (bevacizumab, erlotinib hydrochloride)

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (bevacizumab, erlotinib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (bevacizumab, erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
• Recurrent or metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Must have received a platinum-containing chemotherapy regimen for primary disease
• Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval \> 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum
• Patients with a treatment-free interval \< 12 months do not require prior chemotherapy for recurrent disease
• No evidence of CNS disease, including primary brain tumors or brain metastasis
• Performance status - ECOG 0-2
• More than 3 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No history of bleeding diathesis
• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
• Bilirubin normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Gini Fleming

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2005
• First Posted: August 4, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: April 1, 2010
• Last Updated: May 14, 2014

Record last verified: 2012-12

Locations

US (1)