First-Line Capecitabine and Cetuximab for Metastatic Colorectal Ca in Elderly Patients
This study has been terminated.
Cancer Institute of New Jersey
Information provided by:
Rutgers, The State University of New Jersey
First received: November 7, 2005
Last updated: January 25, 2010
Last verified: January 2010
This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.
Drug: Capecitabine and Cetuximab
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets
Primary Outcome Measures:
- Primary Objective
- To measure the response (CR/PR) for a novel chemotherapy/biologic combination-capecitabine/cetuximab for patients with metastatic colorectal cancer who are too fragile for more intensive chemotherapy doublet regimens.
Secondary Outcome Measures:
- Secondary Objectives
- To measure progression-free survival and document overall survival in this patient population.
- To assess the toxicity of capecitabine/cetuximab
- To describe the baseline quality of life and functional characteristics of elderly patients or those with multiple comorbidities enrolled in this study and assess the impact of disease and its treatment on such functional characteristics.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with uncontrolled systemic disease other than the patient's colorectal cancer (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) for which the patient was admitted to the hospital within the prior month. Patients with stable respiratory, cardiac, hepatic or renal disease may participate subject to the guidelines in the eligibility criteria above.
- Presence of dementia or delirium.
- Unable to eat, dress, bathe or use the toilet independently. The patient must be able to ambulate independently unless limited by arthritis or musculoskeletal condition.
- Patients with active gastritis within the last 3 months prior to study entry.
- No synchronous or prior malignancy other than non-melanomatous skin cancer or insitu carcinoma of the cervix, unless disease free > 3 years.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus. Women must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Men and women must be willing to use adequate birth control measures to prevent contraception.
- Inability to or unwillingness to comply with protocol defined treatment and assessments.
- Prior therapy that specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
- Patients ingesting herbal supplements, botanicals or vitamins in excess of recommended daily dose must be willing to stop their use, 1 week prior to study entry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251186
|The Cancer Institute of New Jersey
|New Brunswick, New Jersey, United States, 08901 |
University of Medicine and Dentistry New Jersey
Cancer Institute of New Jersey
||Elizabeth Poplin, MD
||Rutgers, The State University of New Jersey
No publications provided
History of Changes
|Other Study ID Numbers:
||5536, CINJ 070502
|Study First Received:
||November 7, 2005
||January 25, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action