Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced breast cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Tipifarnib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast

• Phase I (closed to accrual as of 1/19/04):

• Nonregional stage IV disease

• Phase II:

• Locally advanced disease, according to AJCC staging criteria:

• Stage IIB

• Stage IIIA

• Stage IIIB

• Stage IIIC

• At least 1 bidimensionally or unidimensionally measurable indicator lesion

• Hormone receptor status:

• Not specified

• Female

• Performance status - ECOG 0-1

• Performance status - Karnofsky 70-100%

• Not specified

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin normal

• AST/ALT no greater than 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• LVEF normal

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No other invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other agents used in the study (e.g., imidazoles or quinolones)

• No ongoing or active infection

• No other concurrent uncontrolled illness that would preclude study participation

• No psychiatric illness or social situation that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Not specified

• Phase I (closed to accrual as of 1/19/04):

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No more than 1 prior adjuvant/neoadjuvant regimen and 1 prior regimen for metastatic disease

• Prior doxorubicin allowed provided the following are true:

• Used in adjuvant setting

• Cumulative dose was no greater than 240 mg/m^2

• At least 1 year between completion of adjuvant therapy and relapse

• Phase II:

• No prior chemotherapy for locally advanced breast cancer

• At least 1 week since prior tamoxifen or other selective estrogen receptor modulators for prevention or other indications (e.g., osteoporosis, ductal carcinoma in situ, or invasive breast cancer)

• Phase I (closed to accrual as of 1/19/04):

• More than 4 weeks since prior radiotherapy

• Phase II:

• No prior radiotherapy for locally advanced breast cancer

• Not specified

• No antacids within 2 hours of study drug administration

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer therapy

• No other concurrent investigational agents