NCT00004879

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2000

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

5.3 years

First QC Date

March 7, 2000

Last Update Submit

January 7, 2013

Conditions

Colorectal CancerEsophageal CancerKidney CancerLung CancerPancreatic CancerProstate Cancer

Keywords

recurrent renal cell cancerrecurrent prostate cancerrecurrent colon cancerrecurrent rectal cancerrecurrent non-small cell lung cancerrecurrent pancreatic cancerrecurrent esophageal cancer

Interventions

panitumumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1738, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsKidney NeoplasmsLung NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsCarcinoma, Renal CellColonic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Arie Belldegrun, MD, FACS

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

July 1, 2005

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(2)