Duarte, California 91010

  • Breast Cancer

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.


Study summary:

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.


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


Study is Available At:


Original ID:

98096


NCT ID:

NCT00004092


Secondary ID:

U01CA063265


Study Acronym:


Brief Title:

Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

City of Hope Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

72


Enrollment Type:

Actual


Overall Contact Information

Official Name:George Somlo, MD
Principal Investigator
City of Hope Medical Center

Study Dates

Start Date:May 1999
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 12, 2015
First Received Date:December 10, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of novel clonal hematopoietic abnormalities
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Toxicity profile
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Reduction in the degree of developing osteoporosis
Time Frame:4 years post treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to platelet independence
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to engraftment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Treatment-related mortality
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Overall survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of grade IV toxicity
Time Frame:4 weeks post last course of treatment
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Disease-free survival
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Description:Patients receive autologous peripheral blood stem cells
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)
Intervention Type:Drug
Name:thiotepa
Description:Given IV
Arm Name:Arm II (STAMP V)
Intervention Type:Drug
Name:paclitaxel
Description:Given IV
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)
Intervention Type:Drug
Name:doxorubicin hydrochloride
Description:Given IV
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)
Intervention Type:Drug
Name:cyclophosphamide
Description:Given IV
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)
Intervention Type:Drug
Name:carboplatin
Description:Given IV
Arm Name:Arm II (STAMP V)
Intervention Type:Biological
Name:filgrastim
Description:Given IV or subcutaneously
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm II (STAMP V)
Description: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.
Study Arm Type:Experimental
Arm Name:Arm I (ACT) (closed to accrual as of 4/6/2006)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:City of Hope Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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