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


Phase 1
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Virginia Kwitkowski, MS, RN, CS, CRNP

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

950015

NCT ID:

NCT00019019

Start Date:

October 1994

Completion Date:

July 2006

Related Keywords:

  • 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
  • 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
  • stage IV non-small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • adult anaplastic astrocytoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult central nervous system germ cell tumor
  • primary central nervous system non-Hodgkin lymphoma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult ependymoblastoma
  • adult pineocytoma
  • adult pineoblastoma
  • adult meningeal hemangiopericytoma
  • intraocular lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • adult choroid plexus tumor
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult grade III meningioma
  • adult oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • 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

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Medical Oncology Clinical Research UnitBethesda, Maryland  20892