Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047151
First received: October 3, 2002
Last updated: March 22, 2010
Last verified: May 2004
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan, leucovorin, and fluorouracil with ABX-EGF in treating patients who have metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: panitumumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil in Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
Panitumumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | July 2002 |
OBJECTIVES:
- Determine progression-free survival of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and fluorouracil.
- Determine additional measures of clinical efficacy of this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of monoclonal antibody ABX-EGF when administered with this regimen in these patients.
- Determine the pharmacokinetics of irinotecan and its active metabolite SN-38 when administered with this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour, irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 5 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed within 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 84 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 confirmed colorectal cancer
- Metastatic disease
- Must have been free of disease for at least 1 year if received prior adjuvant fluorouracil
- Epidermal growth factor receptor (EGFR) over-expression by immunochemistry (staining 2+ or 3+ in at least 10% of tumor cells)
- Unidimensionally measurable disease
- No clinically significant ascites or pleural effusion
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2.2 mg/dL
Cardiovascular
- LVEF at least 45% by MUGA
- No myocardial infarction within the past year
Other
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
- No chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior irinotecan
Endocrine therapy
- Not specified
Radiotherapy
- No prior or concurrent radiotherapy for colorectal cancer
Surgery
- Prior surgery for colorectal cancer allowed
Other
- At least 30 days since prior investigational drugs
- No other prior therapy for colorectal cancer
- No prior therapy for metastatic disease
- No prior EGFR-targeting agents
- No concurrent prochlorperazine during days 1-29 of each study course
- No other concurrent EGFR-targeting agents
- No other concurrent investigational drugs
- No other concurrent therapy for colorectal cancer
- No concurrent investigational supportive care therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047151
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-7187 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Joel Randolph Hecht, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00047151 History of Changes |
| Other Study ID Numbers: | CDR0000257266, UCLA-0203073, IMMUNEX-054.0009, NCI-G02-2115 |
| Study First Received: | October 3, 2002 |
| Last Updated: | March 22, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV 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 Fluorouracil Irinotecan Camptothecin Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 22, 2013