Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

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

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven unresectable locally advanced or metastatic breast cancer

• Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines

• At least one bidimensionally measurable lesion

• No brain metastasis

• No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease

• Hormone receptor status:

• Known hormone receptor status

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

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

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

Hepatic:

• AST and ALT no greater than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

• Bilirubin normal

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled angina or arrhythmia

• No myocardial infarction within the past 6 months

• No New York Heart Association class III or IV heart disease

Other:

• No sensitive neuropathy worse than grade 2

• No other significant, uncontrolled medical or psychiatric condition

• No serious active infection

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior specific antitumoral immunotherapy

Chemotherapy:

• See Disease Characteristics

• No prior taxanes

• At least 4 weeks since other prior specific antitumoral chemotherapy

Endocrine therapy:

• At least 4 weeks since prior specific antitumoral hormonal therapy

Radiotherapy:

• At least 4 weeks since prior specific antitumoral radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent experimental medication