Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCCRC-12044B NCI-5814, NCT00062127, 5814

Objectives

1. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.
2. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.
3. Determine the toxicity of this regimen in these patients.
4. Determine the observed antitumor response in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed malignant solid tumor
  • Metastatic or unresectable
  • Standard curative or palliative therapy is no longer effective or does not exist



• Measurable or assessable disease



• No uncontrolled brain metastases
  • Patients with brain metastases are eligible provided the following are true:
    • Stable neurologic status
    • At least 4 weeks since prior steroids or anticonvulsants
    • No neurologic dysfunction that would confound evaluation

Prior/Concurrent Therapy:

Biologic therapy

• At least 4 weeks since prior biologic therapy

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• More than 28 days since prior major surgical procedure or open biopsy

Other

• At least 4 weeks since prior investigational therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or commercial agents or therapies for the malignancy

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin normal
• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal

• No history of inflammatory bowel disease requiring therapy
• No chronic diarrhea syndromes
• No paralytic ileus

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation
• Male patients must use effective barrier contraception during and for 4 weeks after study participation
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
• No uncontrolled seizure disorder
• No other concurrent uncontrolled illness that would preclude study participation
• No psychiatric illness or social situation that would preclude study compliance
• No ongoing or active infection
• No significant traumatic injury within the past 28 days
• No serious, nonhealing wounds or ulcers
• No bone fractures
• No preexisting peripheral neuropathy grade 2 or greater

Expected Enrollment

A total of 35 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Apurva Desai, Protocol chair		Ph: 773-702-9200; 888-824-0200

Registry Information
Official Title		A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients with Advanced Solid Tumors
Trial Start Date		2003-04-29
Registered in ClinicalTrials.gov		NCT00062127
Date Submitted to PDQ		2003-04-24
Information Last Verified		2005-06-02
NCI Grant/Contract Number		CA69852, CA14599

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