Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00296062
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Phase II: IV over 30-90 minutes on days 1 and 15 of each course.
  • capecitabine — DRUG
    Phase I: oral capecitabine twice daily on days 1-7 and 15-21.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine (during both odd- and even-numbered courses) until the maximum tolerated dose (MTD) is determined.Phase II:receive capecitabine (at the MTD determined in phase I(odd-numbered courses)
  • irinotecan hydrochloride — DRUG
    Phase I: irinotecan hydrochloride IV over 90 minutes on days 1 and 15 during course 1 and all subsequent odd-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Phase II: receive capecitabine (at the MTD determined in phase I) in combination with irinotecan hydrochloride (during odd-numbered courses)
  • oxaliplatin — DRUG
    Phase I: oxaliplatin IV over 2 hours on days 1 and 15 during course 2 and all subsequent even-numbered courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Phase II: oxaliplatin (during even-numbered courses) as in phase I

Study Details

RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin with or without bevacizumab and to see how well they work in treating patients with metastatic or locally advanced colorectal cancer or other solid tumors that cannot be removed by surgery.

Key Dates

Start date
Mar 31, 2006
Status verified
Jan 2012
Primary completion
Oct 31, 2009
Completion
May 31, 2011

Study Design

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

Primary Outcome Measure

Phase II: Bevacizumab plus dose-intense capecitabine in combination with alternating full-dose irinotecan hydrochloride and oxaliplatin as first-line treatment leads to an improved response rate in patients with metastatic colorectal cancer [ Time Frame: Courses repeat every 28 days in the absence of unacceptable toxicity. ]

Locations (1)

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

Find similar trials in Cleveland, OH

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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