Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003711|
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : May 30, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who have metastatic solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: pemetrexed disodium||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of LY231514 followed by irinotecan in patients with metastatic cancer. II. Determine the quantitative and qualitative toxicity of LY231514 in combination with irinotecan in these patients. III. Assess plasma pharmacokinetics in these patients treated with this regimen. IV. Document any antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive LY231514 IV over 10 minutes followed by irinotecan IV over 90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression and unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of LY231514 and irinotecan. If escalation of one drug in the combination results in unacceptable dose limiting toxicity (DLT), the drug is not escalated further. Instead, the dose of that drug is decreased to its safe dose, and the second drug is escalated until unacceptable DLT results. If DLT occurs in 2 of up to 6 patients at any level, dose escalation is stopped. The maximum tolerated dose is defined as the highest dose at which fewer than 2 of 6 patients experience DLT during courses 1 or 2.
PROJECTED ACCRUAL: Up to 42 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer|
|Study Start Date :||September 1997|
|Actual Study Completion Date :||September 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003711
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Thomas R. Johnson, MD||San Antonio Cancer Institute|