Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
This study has been terminated.
(Enrollment closed 10/15/2008 based on data about KRAS.)
Sponsor:
Fox Chase Cancer Center
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00321100
First received: May 1, 2006
Last updated: March 1, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Drug: bevacizumab Drug: Cetuximab Drug: Oxaliplatin Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Fox Chase Cancer Center:
Primary Outcome Measures:
- Determine the objective response rate using RESIST criteria after every second cycle [ Time Frame: every 6-9 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine time to progression [ Time Frame: every 6-9 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Cetuximab 250mg/m2 IVweekly of each 21 day cycle; Oxaliplatin 130mg/m2 IVday 1 of each 21 day cycle; Capecitabine 850mg/m2 PO days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
|
Drug: bevacizumab
Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
Other Name: Avastin
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly each 21 day cycle
Drug: Oxaliplatin
Oxaliplatin 130mg/m2 IV day 1 every 21 days
Drug: Capecitabine
Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Other Name: Xeloda
|
|
Active Comparator: B
Cetuximab 250mg/m2 IV weekly for each 21 day cycle
|
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly each 21 day cycle
|
Detailed Description:
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- measurable metastatic adenocarcinoma of the colon or rectum
- no prior systemic therapy for metastatic disease
- adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
- must have tumor tissue available for EGFR and thymidine phosphorylase evaluation
- ECOG PS 0-1
- age >/= 18
- adequate organ function: WBC>/=3,000, ANC >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5X ULN, AST&ALT </= 2.5X ULN, create clearance >/= 50mL/min
- negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
- ability to understand and willing to sign written ICF
- able to swallow and absorb oral medication
Exclusion Criteria:
- medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing)
- history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
- surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
- urine protein:creatinine ration >/=1.0 at screening
- evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
- prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin
- underlying neuropathy >/= grade 2
- TIA or CVA w/in 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321100
Locations
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
| Principal Investigator: | Steven Cohen, MD | Fox Chase Cancer Center |
More Information
No publications provided
| Responsible Party: | Steven J. Cohen, MD, Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00321100 History of Changes |
| Other Study ID Numbers: | FRN-GI-002 |
| Study First Received: | May 1, 2006 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fox Chase Cancer Center:
|
metastatic colorectal cancer initial therapy |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Capecitabine Bevacizumab Cetuximab |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013