Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III or IV adenocarcinoma of the breast

• Phase I:

• Evaluable disease allowed

• Phase II:

• At least 1 site of measurable disease

• No bone metastasis as only site of disease

• No carcinomatous meningitis or brain metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

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

• No active coagulopathy requiring therapeutic anticoagulation

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

• No Gilbert's disease

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• Left ventricular ejection fraction at least 50% without clinical signs or symptoms of heart failure

• No uncontrolled hypertension (sustained systolic blood pressure (BP) greater than 180 mm Hg or diastolic BP greater than 100 mm Hg)

• No uncontrolled cardiac arrhythmia

• No myocardial infarction within the past year

• No significant ischemia or valvular heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No medical or psychiatric condition that would increase risk

• No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer

• No grade 2 or greater peripheral neuropathy

• No diabetes mellitus with a fasting blood sugar greater than 200 mg/dL

• No active unresolved infection

• No serious concurrent medical illness

• No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior flavopiridol

• Prior adjuvant chemotherapy for advanced disease allowed if within 6 months of diagnosis of metastatic disease

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or 8 weeks for UCN-01) and recovered

• Phase I:

• Any number of prior chemotherapy regimens for metastatic carcinoma of the breast allowed

• Phase II:

• No more than 2 prior chemotherapy regimens for metastatic carcinoma of the breast

Endocrine therapy:

• Prior hormonal therapy in the metastatic or adjuvant setting allowed

• At least 2 weeks since prior hormonal therapy and no evidence of disease improvement by radiography after therapy

• Concurrent corticosteroids allowed if for study premedication or hypersensitivity reactions/adverse events

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent antineoplastic therapies

• No other concurrent investigational drugs