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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001384
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.

Condition Intervention Phase
Breast Cancer Breast Neoplasms Drug: Adriamycin Drug: cyclophosphamide Drug: G-CSF Drug: paclitaxel Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 35
Study Start Date: May 1994
Estimated Study Completion Date: February 2001
Detailed Description:
This is a pilot feasibility trial of AC (Adriamycin® (Registered Trademark), cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol® (Registered Trademark) (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001384


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001384     History of Changes
Other Study ID Numbers: 940145
94-C-0145
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: April 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
14-Day Cycle
Dose Intensity
Filgrastim
Lymph Node Positive
Non-Cross Resistant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic