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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00008034 |
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 and shrink tumors so they can be removed during surgery.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: cyclophosphamide Drug: epirubicin hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer |
| Study Start Date: | February 2000 |
OBJECTIVES: I. Determine the toxicity of neoadjuvant capecitabine, cyclophosphamide, and epirubicin in women with locally advanced or inflammatory or large operable breast cancer. II. Determine the maximum tolerated dose of this regimen in this patient population.
OUTLINE: This is a multicenter dose escalation study of capecitabine. Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 3-33 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Locally advanced or inflammatory disease (T4, any N or any T, N2 or N3 or T4d) OR Large operable disease (large T2 or T3 for which tumor shrinkage is needed) No distant metastasis on chest x-ray, liver ultrasound, or bone scan except for ipsilateral supraclavicular nodes No abnormal bone scintigrams that cannot be confirmed as benign Hormone Receptor Status Not specified
PATIENT CHARACTERISTICS: Age: 18 to 70 Sex: Female Menopausal status: Not specified Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: LVEF normal by echocardiography or MUGA Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious uncontrolled illnesses No uncontrolled psychiatric or addictive disorders No other concurrent or prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Contacts and Locations| Switzerland | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| Study Chair: | Herve Bonnefoi, MD | Hopital Cantonal Universitaire de Geneve |
More Information
| Study ID Numbers: | CDR0000068365, EORTC-10991, IDBBC-10991-CEX |
| Study First Received: | January 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00008034 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer inflammatory breast cancer |
|
Antimetabolites Capecitabine Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Epirubicin |
Immunosuppressive Agents Anti-Bacterial Agents Inflammatory Breast Cancer Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic |
Epirubicin Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
