First-Line Capecitabine and Cetuximab for Metastatic Colorectal Ca in Elderly Patients

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00251186
• Other study ID #: 5536
• Secondary ID: CINJ 070502
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2005
• Last updated: January 25, 2010
• Start date: April 2006
• Est. completion date: April 2006

Study information

• Verified date: January 2010
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Histologically or cytologically proven diagnosis of locally extensive or metastatic colorectal cancer, not amenable to curative therapy.

• No prior therapy for metastatic disease. Only 5-fluorouracil and leucovorin chemotherapy in the adjuvant setting will be allowed and the last treatment was given more then 6 months prior to metastatic disease development.

• Patients with an ECOG performance score of 2 AND/OR Charlson comorbidity index of ³ 4.

• Patients must be documented by the physician to be medically unable to tolerate oxaliplatin and/or irinotecan based chemotherapy.

• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³10 mm with spiral CT scan.

• Life expectancy of greater than 3 months.

• Laboratory values showing adequate organ function prior to going on-study:

• Absolute neutrophil count (ANC) = 2.5 x 109/L

• Platelets (PLT) 100 x 109/L

• Hemoglobin 9g/dl (with or without transfusion)

• Metabolic:Calculated creatinine clearance > 50 ml/min

• Total Bilirubin £ 1.5 x Upper limit of normal (ULN)

• AST £ 3 x ULN

• Patient should be able to ingest oral medication.

• Ability to understand and sign an approved informed consent.

Exclusion Criteria

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine and Cetuximab

Locations

Country	Name	City	State
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Bristol-Myers Squibb, Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective
Primary	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	Secondary Objectives
Secondary	To measure progression-free survival and document overall survival in this patient population.
Secondary	To assess the toxicity of capecitabine/cetuximab
Secondary	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.