Completed

NCT Number: NCT00019019

Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Adenocarcinoma Adnexal Diseases Astrocytoma Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Chronic Disease Craniopharyngioma DNA Virus Infections Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Epstein-Barr Virus Infections Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intraocular Lymphoma Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Cancer Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Medulloblastoma Melanoma Melanoma (Skin) Meningeal Neoplasms Meningioma Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroendocrine Tumors Nevi and Melanomas Oligodendroglioma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pinealoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Respiratory Tract Diseases Respiratory Tract Neoplasms Sezary Syndrome Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Intestine Cancer Thoracic Neoplasms Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NCI - Medical Oncology Clinical Research Unit, Bethesda, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboxyamidotriazole

Drug

paclitaxel

Drug

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA

Important dates

Study start: 1994
Primary completion: 2006
Study completion: 2006
First posted: Jan 27, 2003
Registry last updated: Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed