Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
This study has been terminated.
(The study drugs are not covered anymore by insurance.)
Sponsor:
National Cancer Center, Korea
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00506168
First received: July 23, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Secondary Drug Therapy, Combination |
Drug: Irinotecan, Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Center, Korea:
Primary Outcome Measures:
- Maximal response rate and toxicities [ Time Frame: During treatment ]
Secondary Outcome Measures:
- Progression-free survival and overall survival
| Enrollment: | 37 |
| Study Start Date: | November 2001 |
| Study Completion Date: | July 2007 |
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.
Response assessment will be performed every 3 cycles of chemotherapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00506168 History of Changes |
| Other Study ID Numbers: | NCCCTS-01-024 |
| Study First Received: | July 23, 2007 |
| Last Updated: | July 23, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by National Cancer Center, Korea:
|
Colorectal neoplasms Secondary Drug therapy, combination Irinotecan Capecitabine |
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 Irinotecan Capecitabine Fluorouracil |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 21, 2013