XAD - Xelox (Capecitabine + Oxaliplatin) + Bevacizumab + Dasatinib

Part of paid clinical trials in Denver, Colorado.

Sponsor
Herbert Hurwitz, MD
Study ID
NCT00920868
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • dasatinib — DRUG
    dasatinib at 50 mg PO BID)
  • bevacizumab — DRUG
    7.5 mg/kg IV day 1
  • Oxaliplatin — DRUG
    130 mg/m2 IV day 1
  • Capecitabine — DRUG
    850 mg/m2 PO BID on days 1-14

Study Details

The primary purpose of this study is to find the highest tolerated dose of the study drugs: capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with advanced solid tumors. This will occur in the first part of the study (Phase I). Once this dose has been determined, it will be given to subjects with advanced metastatic colorectal cancer in the second part of the study (Phase II). By giving these drugs in combination, researchers hope to evaluate the side effects of the study drugs in both groups, and to determine if this combination could possibly decrease or stabilize the cancer being treated. Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain Cancer Center. After satisfying eligibility and screening criteria, patients will be treated on 21 day cycles. ABOUT THE STUDY DRUGS * Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form made by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and Drug Administration (FDA) for first line treatment (treatment that should be used for cancer that has not been treated yet) of metastatic colorectal cancer and also for metastatic breast cancer. * Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in metastatic colorectal cancer. * Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic therapy (a type of therapy to treat cancer that interferes with blood flow to the tumor, thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of metastatic colorectal cancer in combination with other chemotherapy. * Dasatinib (Sprycel™) is an oral drug made by Bristol Myers Squib, Inc (BMS). Dasatinib is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients that are resistant to a medicine called imatinib mesylate (Gleevec™ ).

Key Dates

First listed
Jun 15, 2009
Start date
May 31, 2009
Status verified
Feb 2016
Primary completion
May 31, 2010
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: Dasatinib 50mg
    Cohort 1

Primary Outcome Measure

To determine the maximum tolerated dose(MTD)/recommended phase II dose (RPTD) of capecitabine/oxaliplatin/bevacizumab/dasatinib for patients with advanced solid tumors. [ Time Frame: 9 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer CenterDenverColorado80218-
Duke Univeristy Medical CenterDurhamNorth Carolina27710-

Find similar trials in Denver, CO

By research site
Rocky Mountain Cancer Center· Denver, CODuke Univeristy Medical Center· Durham, NC

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