Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
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Purpose
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Esophageal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Prostate Cancer |
Biological: panitumumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer |
| Study Start Date: | April 2000 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
- Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
- Evaluate the clinical effect of this drug in this patient population.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.
NOTE: *All patients receive a total of 4 doses.
Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.
Patients are followed every 2 weeks for 5 weeks.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Renal cell cancer (RCC)
- Prior nephrectomy required
Prostate cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
Pancreatic cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
Non-small cell lung cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
Colorectal cancer
- Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
Esophageal cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Gastroesophageal junction cancer
- Evaluable disease
Epidermal growth factor receptor overexpression
- Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
- No uncontrolled brain metastases
- No evidence of disease progression or regression after a 30-day washout period
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100% OR
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
- Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)
Renal:
- Creatinine less than 2.2 mg/dL
- NCI renal toxicity no greater than grade 2
- No hypercalcemia (antihypercalcemic therapy allowed)
Cardiovascular:
- Ejection fraction at least 45% by MUGA
- No abnormal ECG or MUGA
- No myocardial infarction within the past year
Pulmonary:
- No abnormal chest x-ray
- FEV_1 greater than 50% of predicted
Other:
- No known allergy to ingredients of study drug
- No known allergy to Staphylococcus aureus Protein A
- HIV negative
- No chronic medical or psychiatric condition that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
- No other concurrent biologic therapy
Chemotherapy:
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy and recovered
- No prior chemotherapy for RCC
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Concurrent steroids allowed
- Concurrent hormonal therapy allowed
Radiotherapy:
- See Disease Characteristics
- No prior mediastinal radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any recent prior surgery
Other:
- At least 30 days since prior investigational drug or device
- At least 30 days since prior systemic therapy
- No other concurrent investigational drugs
- No other concurrent systemic agents or cancer therapy
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1738 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004879 History of Changes |
| Other Study ID Numbers: | CDR0000067539, UCLA-9906078, ABX-EG-9901, UCLA-9906078-04B, NCI-G00-1673 |
| Study First Received: | March 7, 2000 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
recurrent renal cell cancer recurrent prostate cancer recurrent colon cancer recurrent rectal cancer |
recurrent non-small cell lung cancer recurrent pancreatic cancer recurrent esophageal cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Pancreatic Neoplasms Prostatic Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Head and Neck Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 21, 2013