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HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER


Phase 1/Phase 2
15 Years
60 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER


OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide,
and carboplatin followed by autologous stem cell rescue in women with breast cancer
considered incurable by conventional therapy. II. Observe the overall response rate,
survival rate, and toxicity associated with this regimen.

OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC)
on another protocol; patients with marrow involvement undergo PBSC harvest only, while all
others may also undergo bone marrow harvest. All patients receive cyclophosphamide,
etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone
marrow and granulocyte colony-stimulating factor. Patients are followed for duration of
remission and survival.

PROJECTED ACCRUAL: 100-200 patients will be entered.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed invasive (stage II-IV) carcinoma of the
breast 8 or more positive axillary nodes required for stage II disease
Chemotherapy-responsive disease required of patients with measurable or evaluable disease
Partial or complete response to 3 courses of standard
cyclophosphamide/doxorubicin/fluorouracil (CAF) or, for patients who have had CAF,
cyclophosphamide/methotrexate/fluorouracil (CMF) 3-month course of standard
mitomycin/vinblastine or paclitaxel acceptable in patients clearly resistant to CAF or CMF
Visceral response despite progression in bone will be considered on an individual basis
Patients with no evidence of disease may be entered without evidence of a chemotherapy
response Resectable disease must be surgically removed prior to transplantation Hormone
receptor status: If estrogen-receptor positive, prior failure with at least 1 hormonal
manipulation required unless patient is premenopausal or has rapidly progressing visceral
disease No more than 20% of marrow involved with tumor

PATIENT CHARACTERISTICS: Age: 15 to 60 Sex: Women only Menopausal status: Not specified
Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 4,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL AST less than 2 times
normal Albumin at least 3.0 g/dL Renal: Creatinine less than 1.8 mg/dL BUN less than 20
mg/dL Cardiovascular: Left ventricular ejection fraction at least 55% Pulmonary: DLCO,
FEV1, and FVC at least 50% of predicted pO2 at least 70 mm Hg on room air Other: No
serious psychiatric, neurologic, or medical illness that would compromise the safety of a
bone marrow transplant Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior
chest irradiation other than to locally involved lymph nodes Surgery: See Disease
Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas R. Klumpp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000078064

NCT ID:

NCT00002509

Start Date:

November 1991

Completion Date:

December 2003

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Temple University Cancer CenterPhiladelphia, Pennsylvania  19140