Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
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Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: panitumumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma |
| Enrollment: | 44 |
| Study Start Date: | July 2002 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF.
- Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-100 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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal carcinoma
- Diagnosed by fine-needle aspirate or tissue biopsy
- Metastatic disease
- No squamous cell carcinoma
Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially
- Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR
- Evidence of relapse within 12 months after last dose of adjuvant therapy
- Bidimensionally measurable disease
Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry
- Must be 2+ or 3+ in at least 10% of evaluated tumor cells
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
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
- 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 that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior EGFr-targeting agents or biological agents with antitumor activity
Chemotherapy:
- See Disease Characteristics
- At least 30 days since prior systemic chemotherapy
- No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine)
- No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 30 days since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 30 days since other prior anticancer therapy
- No prior investigational drug with potential antitumor activity
- No other concurrent investigational drugs
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Principal Investigator: | Joel Randolph Hecht, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00039273 History of Changes |
| Other Study ID Numbers: | CDR0000069368, UCLA-0112063, IMMUNEX-054-0005, NCI-G02-2073 |
| Study First Received: | June 6, 2002 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013