Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00006465 | Completed Phase 1 DMC

• 5 other identifiers: CWRU5Y99U01CA062502P30CA043703CWRU-5Y99NCI-370
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.

  Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity.

Interventions

capecitabine DRUG

Patients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).

irinotecan hydrochloride DRUG

Patients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).

Also known as: camptothecin-11, irinotecan, irinotecan HCl

oxaliplatin DRUG

Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Also known as: diaminocyclohexane oxalatoplatinum, oxalatoplatin, oxalatoplatinum

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy * Bidimensionally measurable or evaluable disease * No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT less than 2 times normal Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No known hypersensitivity to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior large-field radiotherapy and recovered Surgery: * Not specified

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• Krishnamurthi SS, Brell JM, Hoppel CL, Egorin MJ, Weaver KC, Li X, Ingalls ST, Zuhowski EG, Schluchter MD, Dowlati A, Cooney MM, Gibbons J, Overmoyer BA, Ivy SP, Remick SC. Phase I clinical and pharmacokinetic study of oxaliplatin, irinotecan and capecitabine. Cancer Chemother Pharmacol. 2009 Feb;63(3):441-50. doi: 10.1007/s00280-008-0754-2. Epub 2008 Apr 15.

  PMID: 18414865 RESULT

MeSH Terms

Interventions

Capecitabine; Irinotecan; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Scot C. Remick, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Primary Completion: November 1, 2003
• Study Completion: April 1, 2005
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)