We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004092
First Posted: January 27, 2003
Last Update Posted: August 4, 2015
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.


Condition Intervention Phase
Breast Cancer Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: thiotepa Procedure: peripheral blood stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Five-Year Relapse-free Survival [ Time Frame: Five years ]
    RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.


Secondary Outcome Measures:
  • Five-Year Overall Survival [ Time Frame: Five Years ]
    Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.


Enrollment: 72
Study Start Date: May 1999
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (ACT) (closed to accrual as of 4/6/2006)
Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
Biological: filgrastim
Given IV or subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV
Procedure: peripheral blood stem cell transplantation
Patients receive autologous peripheral blood stem cells
Active Comparator: Arm II (STAMP V)
Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.
Biological: filgrastim
Given IV or subcutaneously
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: thiotepa
Given IV
Procedure: peripheral blood stem cell transplantation
Patients receive autologous peripheral blood stem cells

Detailed Description:

OBJECTIVES:

  • Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I closed to accural as of 4/6/2006.)
  • Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients.
  • Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after high-dose chemotherapy in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage of disease.

Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.

All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)

  • Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
  • Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.

Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.

Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis

    • Stage II with at least 10 positive axillary nodes OR
    • Stage IIIA or IIIB
  • No histologically proven bone marrow metastasis
  • No CNS metastasis
  • Hormone receptor status:

    • Hormone receptor status known

PATIENT CHARACTERISTICS:

Age:

  • Physiological age 60 or under

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • See Disease Characteristics

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT or SGPT no greater than 2 times upper limit of normal
  • Hepatitis B antigen negative

Renal:

  • Creatinine no greater than 1.2 mg/dL
  • Creatinine clearance at least 70 mL/min
  • No prior hemorrhagic cystitis

Cardiovascular:

  • Ejection fraction at least 55% by MUGA
  • No prior significant valvular heart disease or arrhythmia

Pulmonary:

  • FEV_1 at least 60% of predicted
  • pO_2 at least 85 mm Hg on room air
  • pCO_2 at least 43 mm Hg on room air
  • DLCO at least 60% lower limit of predicted

Other:

  • No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix
  • No CNS dysfunction that would preclude compliance
  • HIV negative
  • No sensitivity to E. coli-derived products
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No prior doxorubicin of total dose exceeding 240 mg/m^2
  • No prior paclitaxel of total dose of at least 750 mg/m^2
  • No more than 12 months since prior conventional-dose adjuvant chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiation to the left chest wall

Surgery:

  • Not specified
  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): NCT00004092


Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: George Somlo, MD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00004092     History of Changes
Other Study ID Numbers: 98096
U01CA063265 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-98096
CHNMC-PHII-18
NCI-H99-0038
CDR0000067305 ( Registry Identifier: NCI PDQ )
First Submitted: December 10, 1999
First Posted: January 27, 2003
Results First Submitted: July 7, 2015
Results First Posted: August 4, 2015
Last Update Posted: August 4, 2015
Last Verified: July 2015

Keywords provided by City of Hope Medical Center:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Cyclophosphamide
Carboplatin
Doxorubicin
Thiotepa
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