Know Cancer

or
forgot password

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


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer, Breast Neoplasms

Thank you

Trial Information

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 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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

940145

NCT ID:

NCT00001384

Start Date:

May 1994

Completion Date:

February 2001

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • 14-Day Cycle
  • Dose Intensity
  • Filgrastim
  • Lymph Node Positive
  • Non-Cross Resistant
  • Breast Neoplasms
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892