Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center; Rachel Layman
• Collaborators: Genentech, Inc.; National Comprehensive Cancer Network
• Treatments: Bendamustine Hydrochloride; Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer meeting 1 of the following criteria:

• Unresectable stage IIIB or IIIC disease

• Stage IV disease

• Must be negative for all of the following:

• Estrogen receptor (< 10%)

• Progesterone receptor (<10%)

• HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)

• Measurable or evaluable disease

• No symptomatic or progressive CNS (central nervous system) metastases

• Previously treated CNS metastases allowed provided all of the following criteria are met:

• At least 8 weeks since prior radiation to brain or CNS metastases

• No concurrent steroids

• No leptomeningeal disease

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2

• Life expectancy ≥ 6 months

• WBC > 1,500/mm³

• Platelet count > 100,000/mm³

• Creatinine clearance > 40 mL/min

• Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN in the presence of documented liver metastases)

• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver or bone metastases)

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception

• No uncontrolled intercurrent illness

• No active infection requiring systemic therapy

• Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:

• Uncontrolled nausea, vomiting, or diarrhea

• Lack of the physical integrity of the upper gastrointestinal tract

• Malabsorption syndrome

• No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride

• No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities

• No prior bendamustine hydrochloride or EGFR-directed therapy

• No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery

• Intravenous bisphosphonates allowed

• No concurrent antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents