Irinotecan in Treating Patients With Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
USC/Norris Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003843
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: September 2003
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: irinotecan hydrochloride Genetic: mutation analysis Genetic: polymorphism analysis |
Phase 2 |
| Study Type: | Observational |
| Official Title: | UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 (Irinotecan) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 28 |
| Study Start Date: | October 1998 |
OBJECTIVES:
- Determine the frequency of genetic polymorphisms of UGT1 in Hispanics with colorectal cancer.
- Determine if pharmacokinetics of irinotecan and its metabolites, SN38 and SN38G, are associated with the genotype of UGT1 and clinical toxicity.
- Determine whether the genetic polymorphisms of UGT1 are associated with clinical toxicity and pharmacokinetics/pharmacodynamics of irinotecan in patients with unresectable colorectal cancer treated with irinotecan.
- Determine the response, time to progression, and survival in patients with UGT1A1 polymorphisms treated with irinotecan.
OUTLINE: Genomic DNA is isolated from blood samples from patients and analyzed for UGT1 polymorphisms. Patients are stratified according to UGT1 genotype (homozygous for wild type vs heterozygous for abnormal allele vs homozygous for abnormal allele).
Patients receive irinotecan over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven advanced or disseminated colorectal cancer
- Progressive disease on fluorouracil based chemotherapy OR
- Recurrence of disease within 12 months of adjuvant therapy with fluorouracil
- No known CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Granulocyte count greater than 1500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved)
Renal:
- Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 12.0 mg/dL
Cardiovascular:
- No myocardial infarction within past 6 months
- No congestive heart failure requiring therapy
Neurologic:
- No severe psychiatric disorders
- No history of seizures
Other:
- No active or uncontrolled infection
- HIV negative
- No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater)
- No other severe concurrent disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Prior oxaliplatin allowed
- No prior irinotecan or topotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003843
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Investigators
| Study Chair: | Heinz-Josef Lenz, MD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003843 History of Changes |
| Other Study ID Numbers: | CDR0000067003, LAC-USC-3C981, NCI-G99-1513 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan |
Camptothecin 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 |
ClinicalTrials.gov processed this record on May 19, 2013