Full Text View
Tabular View
No Study Results Posted
Related Studies
Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00074321   Information provided by National Cancer Institute (NCI)
First Received: December 10, 2003   Last Updated: July 23, 2008   History of Changes

December 10, 2003
July 23, 2008
November 2003
 
 
 
Complete list of historical versions of study NCT00074321 on ClinicalTrials.gov Archive Site
 
 
 
Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
A Phase I And Pharmacogenetic Study Of CPT-11, Oxaliplatin, And Capecitabine In Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with unresectable solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose of irinotecan, oxaliplatin, and capecitabine in patients with unresectable solid tumors.
  • Determine the activity of this regimen in these patients.
  • Determine the toxicity profile, especially pertaining to hematologic and gastrointestinal toxicity, of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to UGT1A1 genotype (6/6 vs 6/7 [closed to accrual as of 8/24/06] vs 7/7).

Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Courses repeat every 3 weeks.

Cohorts of 3-6 patients receive escalating doses of irinotecan, oxaliplatin, and capecitabine 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. Once the MTD is determined, an additional 6-10 patients (for a total of 12 patients) receive treatment at that dose.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 54-84 patients (12-22 for stratum I, 18-28 for stratum II [closed to accrual as of 8/24/06] , and 24-34 for stratum III) will be accrued for this study within approximately 4.4 years.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: capecitabine
  • Drug: irinotecan hydrochloride
  • Drug: oxaliplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
84
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy

    • Unresectable disease
  • Willing to provide biologic specimens to determine UGT1A1 genotype
  • No CNS metastases

    • Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1 genotype (1.5 times ULN for patients with 6/7 [closed to accrual as of 8/24/06] or 7/7 UGT1A1 genotype)
  • AST no greater than 3 times ULN (5 times ULN if there is liver involvement)

Renal

  • Creatinine no greater than 1.5 times ULN

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
  • No prior allergy to platinum compounds, irinotecan, or to antiemetics or antidiarrheals appropriate for administration with study therapy
  • No uncontrolled infection
  • No seizure disorder
  • No peripheral neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior immunotherapy
  • No concurrent immunotherapy
  • No concurrent prophylactic colony-stimulating factor therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of the bone marrow
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent investigational therapy
  • No concurrent sorivudine, brivudine, lamivudine, or stavudine
  • No concurrent enrollment in any other study involving a pharmacologic agent for symptom control or therapeutic intent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074321
 
CDR0000344367, MAYO-MC0311, NCI-6240
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Matthew P. Goetz, MD Mayo Clinic
Investigator: Matthew M. Ames, PhD Mayo Clinic
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP