Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
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Purpose
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 |
|---|---|---|
|
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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.
- Determine the pharmacokinetics and toxicities of this regimen in these patients.
- Identify diseases for which this combination appears active.
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.
Eligibility| 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
- Slides reviewed at the NCI Laboratory of Pathology
Failure on therapy of proven efficacy for the disease
Prior therapy not required for the following metastatic diseases:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
No brain metastases
- Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed
Measurable or evaluable disease required
- Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR
Elevated PSA associated with prostate cancer
- Other marker-only disease ineligible
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hematocrit at least 27%
Hepatic:
- Liver function tests no greater than 2 times upper limit of normal
- Bilirubin normal
- PT or PTT no greater than 1.25 times upper limit of normal
- Clotting parameters normal
- No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 45 mL/min
- No kidney obstruction
Cardiovascular:
- No cardiac conduction defect requiring antiarrhythmics
- No evidence of myocardial infarction or other myocardial damage within past 6 months
Other:
- HIV negative
- No concurrent infection
- No guaiac-positive stool test
- No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
- Recovery from prior therapy required
Biologic therapy:
- At least 4 weeks since prior biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin)
- No progression on carboxyamidotriazole or paclitaxel
- At least 6 months between treatment and relapse
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy
- No concurrent corticosteroids except as physiologic replacement
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 1 week since prior therapeutic antibiotics
- Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole)
- No concurrent calcium channel blockers
Contacts and Locations| 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) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00019019 History of Changes |
| Obsolete Identifiers: | NCT00001423 |
| Other Study ID Numbers: | 950015, 95-C-0015, NCI-CPB-334, NCI-T94-0006N, CDR0000063881 |
| Study First Received: | July 11, 2001 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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 stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Melanoma Nervous System Neoplasms Ovarian Neoplasms Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms |
Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 22, 2013