Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

NCT00506168 | Terminated Phase 2

• 1 other identifier: NCCCTS-01-024
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Conditions

Colorectal Neoplasms; Secondary; Drug Therapy, Combination

Keywords

Colorectal neoplasms; Secondary; Drug therapy, combination; Irinotecan; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Maximal response rate and toxicities

  During treatment

Secondary Outcomes (1)

• Progression-free survival and overall survival

Interventions

Irinotecan, Capecitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic colorectal cancer
• ECOG performance status 0-2
• Mesurable lesions
• No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
• Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
• Adequate organ functions
• Expected survival is longer then 6 months
• Informed consent

You may not qualify if:

• Prior systemic chemotherapy for metastatic disease
• Prior treatment with oxaliplatin or irinotecan
• CNS metastases
• Uncontrolled or severe cardiovascular disease
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
• Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
• Psychiatric disorder or uncontrolled seizure that would preclude compliance
• Pregnant, nursing women or patients with reproductive potential without contraception
• Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
• Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kyung Hae Jung, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: November 1, 2001
• Study Completion: July 1, 2007
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

KR (1)