- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001384
A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Recently diagnosed patients with histologically proven Stage II breast cancer who have 4 or more positive lymph nodes or patients with stage III breast cancer are eligible for this study.
Patients will be eligible for study either before or after receiving adjuvant radiation therapy.
Patients with stage III disease will be eligible to receive this regimen as neo-adjuvant chemotherapy or as adjuvant therapy if surgery was performed prior to patient referral.
Patients must be previously untreated with chemotherapy.
There must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years. Patients with a prior history of lower stage contralateral breast cancer, treated with surgery, and/or radiation, but not chemotherapy, are eligible for this study.
Performance status (Karnofsky scale) must be greater than 70; ECOG 0 to 2.
Absolute granulocyte count greater than 1500 per microliter and platelet count greater than 100,000 per mm(3).
Liver function tests (SGOT, and total bilirubin) should be less than 2X upper limits of normal. Serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml per min.
The patient must be able to give an informed consent, and to return to NCI for treatment and adequate follow-up for the period the protocol requires.
Patients must be greater than or equal to 18 years of age.
Patients and/or their partners must be willing to practice a non-hormonal method of contraception during therapy and for 6 months following therapy.
Patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol are excluded.
Patients must have a normal ejection fraction by MUGA scan and have no angina. Patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease.
No patients with a history of symptomatic CNS disease.
No patients with allergy to any study medication.
No pregnant or lactating women.
Patients with bleeding disorders are ineligible for study entry as are patients requiring chronic anticoagulation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jones RB, Holland JF, Bhardwaj S, Norton L, Wilfinger C, Strashun A. A phase I-II study of intensive-dose adriamycin for advanced breast cancer. J Clin Oncol. 1987 Feb;5(2):172-7. doi: 10.1200/JCO.1987.5.2.172.
- Wheeler RH, Ensminger WD, Thrall JH, Anderson JL. High-dose doxorubicin: an exploration of the dose-response curve in human neoplasia. Cancer Treat Rep. 1982 Mar;66(3):493-8.
- Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984 Nov;2(11):1281-8. doi: 10.1200/JCO.1984.2.11.1281. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- 940145
- 94-C-0145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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