NCT00005591

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced, metastatic, or recurrent cancer of the pancreas.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 1999

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 9, 2004

Completed
Last Updated

December 13, 2013

Status Verified

April 1, 2007

Enrollment Period

3.5 years

First QC Date

May 2, 2000

Last Update Submit

December 11, 2013

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Interventions

cetuximabBIOLOGICAL
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, metastatic, or recurrent adenocarcinoma of the pancreas that is not amenable to curative surgical resection Immunohistochemical evidence of EGFr expression of 1+ or greater Measurable disease No history of treated or active brain metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 No unstable coagulation disorders Hepatic: AST/ALT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Bilirubin no greater than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No uncontrolled hypertension or arrhythmias No unstable congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent unstable medical condition (e.g., uncontrolled diabetes mellitus or active infections requiring systemic antibiotics, antivirals, or antifungals) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab Chemotherapy: No prior chemotherapy for advanced pancreatic cancer Prior adjuvant chemotherapy following complete surgical resection allowed provided cancer recurrence was first documented more than 6 months after completion of treatment Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless documented disease progression since prior irradiation Surgery: Prior surgical resection allowed Other: At least 4 weeks since other prior investigational agents

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

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CetuximabGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Albert F. LoBuglio, MD

    University of Alabama at Birmingham

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2000

First Posted

August 9, 2004

Study Start

October 1, 1999

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

December 13, 2013

Record last verified: 2007-04