Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
NCT00039273CI-TRIAL-00008830completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panitumumab | Biological | Panitumumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMeropol NJ, Berlin J, Hecht JR, et al.: Multicenter study of ABX-EGF monotherapy in patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1026, 256, 2003.