Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors

NCT00112892 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000427616RPCI-I-32804
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

Interventions

selenium DIETARY_SUPPLEMENT

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• Fakih MG, Pendyala L, Brady W, Smith PF, Ross ME, Creaven PJ, Badmaev V, Prey JD, Rustum YM. A Phase I and pharmacokinetic study of selenomethionine in combination with a fixed dose of irinotecan in solid tumors. Cancer Chemother Pharmacol. 2008 Aug;62(3):499-508. doi: 10.1007/s00280-007-0631-4. Epub 2007 Nov 8.

  PMID: 17989978 RESULT

MeSH Terms

Interventions

Selenium; Irinotecan

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: August 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)