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Capecitabine,Oxaliplatin & Erbitux Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma
This study is currently recruiting participants.
Verified by University of Pennsylvania, February 2009
First Received: July 14, 2006   Last Updated: February 18, 2009   History of Changes
Sponsors and Collaborators: University of Pennsylvania
Bristol-Myers Squibb
Hoffmann-La Roche
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00353457
  Purpose

This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.


Condition Intervention Phase
Rectal Cancer
Drug: Capecitabine, Oxaliplatin and Cetuximab
Radiation: Radiation
Phase II

MedlinePlus related topics: Cancer Radiation Therapy Surgery
Drug Information available for: Oxaliplatin Capecitabine Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Pathologic complete response [ Time Frame: After neoadjuvant treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sphincter function [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • Type of surgery [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: From time of study entry until first documented relapse ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine, Oxaliplatin and Cetuximab
    Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8
    Radiation: Radiation
    45 Gy in 25 fractions, 3-fraction boost 5.4 Gy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed nonmetastatic, measurable, locally advanced (T3 or T4) rectal adenocarcinoma
  • If available, tumor tissue must be sent for investigational immunohistochemical evaluations of EGFR status
  • The distal border of the tumor must be at or below the peritoneal reflection (defined a with 12 cm of the anal verge by proctoscopy)
  • Transmural penetration of the tumor demonstrated by CT + endorectal ultrasound or MRI
  • ECOG PS 0-2
  • No prior chemotherapy, biologic therapy or radiation therapy
  • Age >= 18 years old
  • Laboratory values: ANC >= 1500/mm3; Platelets >= 100,000/mm3; Hgb >= 9 g/dL; Estimated CrCl > 50 mL/min; Serum bilirubin <= 1.5 x ULN; AST and ALT <= 3.0 x ULN; Negative proteinuria based on dip stick reading
  • Patients must either be not of child bearing potential or have a negative pregnancy test upon study enrollment. Patients must agree to continue contraception for 30 days from the date of the last study drug administration.

Exclusion Criteria:

  • Pregnant or lactating woman. Women of childbearing potential with either a positive or no pregnancy test upon study enrollment. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. Patients must agree to continue contraception for 30 days from the date of the last study administration.
  • Life expectancy < 3 months
  • Serious, uncontrolled, concurrent infection(s)
  • Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs < 4 weeks prior to randomization.
  • Prior therapy which specifically and directly targets the EGFR pathway.
  • Prior severe infusion reaction to a monoclonal antibody
  • Any prior therapy with Oxaliplatin
  • Prior pelvic irradiation for any reason
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or known DPD deficiency
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
  • Participation in any investigational drug study within 4 weeks preceding the start of the study treatment
  • Major surgery within 4 weeks of the study treatment, without complete recovery
  • Known, existing uncontrolled coagulopathy
  • Unwillingness to give written informed consent
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study
  • Known allergy or hypersensitivity to platinum-containing drugs
  • Peripheral sensory neuropathy with functional impairment
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Pleural effusions or ascites that causes respiratory compromise
  • Acute hepatitis or known HIV
  • Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with anti-hypertensive regimen; unstable angina pectoris; symptomatic congestive heart failure; myocardial infarction < 6 months prior to randomization; serious uncontrolled cardiac arrhythmia; uncontrolled diabetes; active or uncontrolled infection; impairment of gastrointestinal function or GI disease that may significantly alter the absorption of Capecitabine.
  • Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353457

Contacts
Contact: Lauren Mennine, RN, BSN 215-349-8913 lauren.mennine@uphs.upenn.edu

Locations
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Bristol-Myers Squibb
Hoffmann-La Roche
Investigators
Principal Investigator: Daniel G Haller, M.D. Abramson Cancer Center of University of Pennsylvania
Principal Investigator: James M Metz, M.D. Abramson Cancer Center of University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania ( Daniel Haller, MD )
Study ID Numbers: 803437, UPCC 09204
Study First Received: July 14, 2006
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00353457     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Adjuvant therapy
Rectal cancer
Capecitabine
Oxaliplatin
Cetuximab
Erbitux

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Cetuximab
Adjuvants, Immunologic
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Rectal Neoplasms
Gastrointestinal Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009