NCT00039273

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

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

June 6, 2002

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

June 6, 2002

Last Update Submit

January 7, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Interventions

panitumumabBIOLOGICAL

Eligibility Criteria

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

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Meropol 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.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joel Randolph Hecht, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

May 1, 2003

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(1)