Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00006465
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Dec 31, 2000
Status verified
Jun 2010
Primary completion
Nov 30, 2003
Completion
Apr 30, 2005

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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. [ Time Frame: Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065-

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By research site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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