Protocol Number: 95-C-0015

Title:

A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma

Number:

95-C-0015

Summary:

This is a dosage escalation study to estimate the maximum tolerated dose of paclitaxel and carboxyamidotriazole combination chemotherapy. Groups of 3 to 6 patients receive various doses and schedules of oral carboxyamidotriazole followed by a single 3-hour intravenous infusion of paclitaxel.

Patients are re-treated every 21 days until 2 courses beyond complete response or until disease progression or unacceptable toxicity. Patients who develop neutropenic fever receive granulocyte colony-stimulating factor on subsequent courses.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.

Disease Category:

PROTICD

Keywords:

Dose Escalation

G-CSF

Pharmacokinetics

Metastases

Toxicity

Recruitment Keywords:

None

Conditions:

Lymphoma

Neoplasm

Neoplasm Metastasis

Investigational Drug(s):

Paclitaxel

CAI

G-CSF

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Journal of clinical oncology

Cancer research

Taxol: a novel investigational antimicrotubule

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004