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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019019 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Breast Cancer Kidney Cancer Lung Cancer Lymphoma Melanoma (Skin) Ovarian Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboxyamidotriazole Drug: paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA |
Estimated Enrollment: | 70 |
Study Start Date: | October 1994 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses of treatment.
Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel. Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma
Failure on therapy of proven efficacy for the disease
Prior therapy not required for the following metastatic diseases:
No brain metastases
Measurable or evaluable disease required
Elevated PSA associated with prostate cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
NCI - Medical Oncology Clinical Research Unit | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Virginia Kwitkowski, MS, RN, CS, CRNP | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000063881, NCI-95-C-0015F, NCI-CPB-334, NCI-T94-0006N |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00019019 |
Health Authority: | United States: Federal Government |
adult pineocytoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer recurrent non-small cell lung cancer recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent adult brain tumor small intestine lymphoma adult brain stem glioma adult craniopharyngioma adult medulloblastoma adult meningioma adult glioblastoma stage III melanoma stage IV melanoma recurrent melanoma stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Sezary syndrome Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Ileal Diseases Lymphoma, large-cell, immunoblastic Lung Neoplasms Lymphoma, Large-Cell, Anaplastic Neuroepithelioma Kidney Diseases Endocrine Gland Neoplasms Non-small cell lung cancer Astrocytoma Genital Neoplasms, Female |
Breast Neoplasms Carcinoma Brain Neoplasms Lung Diseases B-cell lymphomas Anaplastic large cell lymphoma Nevus Lymphoma, Non-Hodgkin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Choroid Plexus Neoplasms Lymphoma, Follicular Sezary Syndrome Lymphoma, B-Cell Lymphoma, large-cell |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Neoplasms, Nerve Tissue Nervous System Diseases Calcium Channel Blockers Antimitotic Agents Cardiovascular Agents |
Pharmacologic Actions Adnexal Diseases Membrane Transport Modulators Neoplasms Neoplasms by Site Jejunal Diseases Therapeutic Uses Tubulin Modulators Nevi and Melanomas Antineoplastic Agents, Phytogenic |