Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen.

PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.

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

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI); Norris Cotton Cancer Center
• Treatments: Gefitinib; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Metastatic disease

• Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the following:

• Stable disease for 24 weeks or longer

• Objective tumor response

• Documentation of clinical progression on tamoxifen within the past 6 weeks

• Hormone receptor status:

• Estrogen or progesterone receptor positive on most recently analyzed biopsy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

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

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN OR

• Creatinine clearance ≥ 50 mL/min

Pulmonary

• No clinically active interstitial lung disease

• Patients with asymptomatic chronic stable radiographic changes are eligible

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known hypersensitivity to gefitinib

• No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent trastuzumab (Herceptin®)

Chemotherapy

• No concurrent cytotoxic chemotherapy

Endocrine therapy

• See Disease Characteristics

• At least 2 weeks since other prior tamoxifen

• No concurrent hormone replacement therapy

• No other concurrent antiestrogens, including raloxifene

• No concurrent aromatase inhibitors

• No concurrent megestrol

• Concurrent systemic steroids for reasons other than skin toxicity allowed provided the steroids were initiated before study entry AND dose remains stable

Radiotherapy

• Concurrent palliative radiotherapy as short-term treatment for symptomatic bone metastases allowed provided other evaluable sites of disease are present AND treatment lasts no more than 14 days

Surgery

• Recovered from prior oncologic or other major surgery

• No concurrent surgery during and for 7 days after study treatment

• No concurrent ophthalmic surgery

Other

• Recovered from all prior therapy (except alopecia)

• More than 30 days since prior investigational drugs

• No other concurrent investigational agents

• No concurrent administration of any of the following:

• Phenytoin

• Carbamazepine

• Barbiturates

• Rifampin

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• Systemic retinoids

• CYP3A4 inhibitors (e.g., itraconazole)

• Drugs that cause significant sustained elevation in gastric pH ≥ 5