Know Cancer

or
forgot password

A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors


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

Thank you

Trial Information

A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors


OBJECTIVES:

Primary

- Determine the optimal loading and maintenance doses of selenium necessary to achieve
selenium concentrations exceeding 15 μM when administered with irinotecan in patients
with advanced solid tumors.

Secondary

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the toxic effects of this regimen in these patients.

- Determine any observed tumor response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of selenium.

Patients receive a loading dose* of oral selenium twice daily on days -6 to 0. Patients then
receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1,
8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or
unacceptable toxicity.

NOTE: *The loading dose is administered prior to course 1 only.

Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor

- Metastatic or unresectable disease

- Standard curative or palliative treatments do not exist or are no longer effective OR
treatment with single-agent irinotecan does not constitute a reasonable treatment
option

- No known untreated or progressive brain metastases

- Previously treated brain metastases allowed provided all of the following are
true:

- No significant neurological deficit

- No requirement for anti-epileptic medications

- Disease stable by brain CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- AST and ALT ≤ 3 times upper limit of normal

- Albumin ≥ 3.0 g/dL

- No Gilbert's disease

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No clinically significant cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to receive oral medications

- No active inflammatory bowel disease or chronic diarrhea

- No known HIV positivity

- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to study drugs

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

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

Endocrine therapy

- Not specified

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent Hypericum perforatum (St. John's wort)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:

Yes

Principal Investigator

Marwan Fakih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000427616

NCT ID:

NCT00112892

Start Date:

August 2004

Completion Date:

December 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263