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

Completed · Phase 1

Conditions studied: Solid Tumor, Metastatic Colorectal Cancer

In brief

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 facts

Study ID

NCT00920868

Run by

Herbert Hurwitz, MD

People needed

22

Starts

2009-05-01

Expected to finish

2014-08-01

Last updated by the study team

2016-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Criteria Specific for Dose Escalation (Phase I)
• Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom capecitabine, oxaliplatin, and/or bevacizumab would be considered a standard therapy or therapeutic option.
• Patients must not have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to study day 1.
• Criteria Specific for Expanded Cohort Portion of Trial Only
• Histologically documented adenocarcinoma of the colon or rectum that is metastatic/recurrent disease
• No prior chemotherapy for metastatic/recurrent colorectal cancer. Patients may have received a radiosensitizing dose of 5-fluorouracil or capecitabine for the treatment of local disease in the localized or metastatic setting.
• No history of other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer
• Disease must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Inclusion Criteria for All Participants
• Age >18 years.
• Karnofsky performance status > 70%.
• Life expectancy of at least 3 months.
• Patients must have adequate organ and marrow function as defined below:
• Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
• All women of child bearing potential (WOCBP) MUST have a negative pregnancy test within 7 days prior to first receiving investigational product.
• Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria for ALL Subjects:
• Patients who have had radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for cancer within the 28 days prior to day 1 of the study (ie - first day of study drug treatment).
• Patients who have received any other investigational agents within the 28 days prior to day 1 of study drug treatment.
• Patients with known central nervous system (CNS) metastases.
• Inadequately controlled hypertension
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy. Patients on full-dose anticoagulation are permitted to enroll provided that they have been clinically stable on anti- coagulation.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study drug treatment

Where it is running

• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Duke Univeristy Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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