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A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced 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.


Inclusion Criteria:



- 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

- Performance status - Karnofsky 70-100%

- More than 12 weeks

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

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

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No history of inflammatory bowel disease requiring therapy

- No chronic diarrhea syndromes

- No paralytic ileus

- 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

- At least 4 weeks since prior biologic therapy

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

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of thalidomide on irinotecan hydrochloride pharmacokinetics

Outcome Time Frame:

Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours

Safety Issue:

No

Principal Investigator

Mark Ratain

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02537

NCT ID:

NCT00062127

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470