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| Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003352 |
Purpose
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 II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC) |
| Study Start Date: | June 1998 |
OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II. Determine survival, time to first response, time to progression, and duration of response in these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses. IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.
OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed. When the maximum dose of doxorubicin is reached, treatment continues with docetaxel and cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced (stage IIIB) adenocarcinoma of the breast Bidimensionally measurable disease No active CNS metastases Brain metastases must be controlled for at least 3 months and have other sites of measurable disease No carcinomatous meningitis No lymphangitic lung metastases as the only site of metastatic disease Hormone receptor status: Any estrogen or progesterone receptor status
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than ULN No SGOT and/or SGPT greater than 1.5 times ULN if concomitant with alkaline phosphatase greater than 2.5 times ULN Renal: Calcium no greater than 1.2 times ULN Creatinine no greater than 1.5 times ULN Cardiovascular: LVEF at least institutional lower limit of normal on MUGA scan or echocardiogram No myocardial infarction within 6 months No angina pectoris requiring antianginal medication No history of congestive heart failure No cardiac arrhythmias requiring medication No vascular disease with documented cardiac function compromise No uncontrolled hypertension (diastolic greater than 100 mm Hg) Other: Not pregnant or nursing Fertile patients must use effective barrier contraception No diabetics with fasting blood sugar greater than 200 mg/dL No peripheral neuropathy greater than grade 1 No psychosis or addictive disorders No known hypersensitivity to E. coli-derived drugs
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic breast cancer or non-breast cancer At least 12 months since nontaxane containing adjuvant chemotherapy for primary tumor (in patients with metastatic disease) Prior adjuvant chemotherapy with anthracycline containing regimens allowed (provided total doxorubicin dose did not exceed 240 mg/m2) Endocrine therapy: At least 4 weeks since adjuvant hormone or hormone therapy for metastatic disease (at least 2 weeks for rapidly progressive disease) No concurrent hormonal birth control Radiotherapy: At least 4 weeks since prior radiotherapy Prior breast radiotherapy following lumpectomy allowed No radiotherapy to greater than 30% of bone marrow No prior left chest wall radiotherapy with anthracycline containing adjuvant chemotherapy Surgery: Not specified
Contacts and Locations
Show 166 Study Locations| Study Chair: | Terry Mamounas, MD, MPH, FACS | Aultman Cancer Center at Aultman Hospital |
More Information
| Study ID Numbers: | CDR0000066333, NSABP-BP-58 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003352 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer |
|
Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Recurrence Doxorubicin |
Docetaxel Anti-Bacterial Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
