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| Sponsored by: |
St. Louis University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002627 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used.
PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: mesna Drug: paclitaxel Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 1994 |
OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel when given with high-dose carboplatin/cyclophosphamide with autologous peripheral blood stem cell support in women with high-risk stage II/III breast cancer. II. Assess the nonhematologic toxicities associated with this combination. III. Assess the progression-free and overall survival of these patients following this treatment.
OUTLINE: This is a dose-finding study. All patients undergo collection of peripheral blood stem cells (PBSC) with granulocyte colony-stimulating factor (G-CSF) mobilization prior to high-dose chemotherapy. Cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose (MTD) is found. Paclitaxel is given as a single 6-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days, then carboplatin for 3 days. Four days later, patients receive PBSC and G-CSF for hematopoietic reconstitution. Additional patients are entered at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, then every 4-6 months thereafter.
PROJECTED ACCRUAL: It is expected that 24-30 patients will be accrued; a study duration of 1-1.5 years is anticipated.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the breast of the following stages: Stage II/IIIA disease with 4 or more involved axillary lymph nodes Stage IIIB Inflammatory No bone marrow involvement documented on bone marrow aspiration and biopsy Prior breast cancer allowed Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women only Menopausal status: Not specified Performance status:
Karnofsky 70%-100% Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA No abnormal cardiac conduction documented as second- or third-degree heart block or bundle branch block Pulmonary:
DLCO at least 60% of predicted Other: Not HIV positive No history of second malignancy within 5 years except:
Nonmelanomatous skin cancer In situ carcinoma of the cervix No pregnant women
PRIOR CONCURRENT THERAPY: At least 3 courses of induction therapy required, with regimen at the discretion of the investigator No disease progression during induction
Contacts and Locations| United States, Missouri | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| Study Chair: | Paul J. Petruska, MD | St. Louis University |
More Information
| Study ID Numbers: | CDR0000064016, SLUMC-8038, NCI-V95-0607 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002627 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer inflammatory breast cancer |
|
Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Inflammatory Breast Cancer |
Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Mesna Alkylating Agents Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
