Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Biological: filgrastim; Drug: amifostine trihydrate; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation

• Registration Number: NCT00003927
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.

Detailed Description

OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.

Study Timeline

• Study Start: 1999-05-18
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Dose chemotherapy followed by cell rescue	filgrastim	Doxorubicin, cyclophosphamide, Taxol, amifostine
High Dose chemotherapy followed by cell rescue	amifostine trihydrate	Doxorubicin, cyclophosphamide, Taxol, amifostine
High Dose chemotherapy followed by cell rescue	peripheral blood stem cell transplantation	Doxorubicin, cyclophosphamide, Taxol, amifostine
High Dose chemotherapy followed by cell rescue	cyclophosphamide	Doxorubicin, cyclophosphamide, Taxol, amifostine
High Dose chemotherapy followed by cell rescue	doxorubicin hydrochloride	Doxorubicin, cyclophosphamide, Taxol, amifostine
High Dose chemotherapy followed by cell rescue	paclitaxel	Doxorubicin, cyclophosphamide, Taxol, amifostine

Primary Outcome Measures

Name	Time	Method
Feasibility of high dose chemotherapy in advance breast cancer patients.	Up to death

Trial Locations

Locations (1)

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States