A Phase 1 interventional study of irinotecan hydrochloride and thalidomide in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors
PRIMARY OBJECTIVES:
I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.
II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.
III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.
Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7.
All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Inclusion Criteria:
Histologically confirmed malignant solid tumor
No uncontrolled brain metastases
Patients with brain metastases are eligible provided the following are true:
Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride · Drug: thalidomide · Other: pharmacological study
Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride · Drug: thalidomide · Other: pharmacological study
Given IV
Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Given orally
Also known as: Kevadon, Synovir, THAL, Thalomid
Correlative studies
Also known as: pharmacological studies
Effect of thalidomide on irinotecan hydrochloride pharmacokinetics
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours
Effect of irinotecan hydrochloride on thalidomide pharmacokinetics
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours
Grade 3 or greater toxicities assessed using NCI CTC version 2.0
Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.
Time frame: Up to 3 years
Response assessed using RECIST criteria
Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.
Time frame: Up to 3 years
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)