Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

NCT00225784 | Completed Phase 2 Results DMC

• 1 other identifier: DMS 0432
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Stage I, II, III pancreatic adenocarcinoma; Radiographically measurable disease

Outcome Measures

Primary Outcomes (1)

• Objective Response of Tumor by RECIST 1.0 Criteria

  Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

  one month post-therapy

Secondary Outcomes (6)

• Number of Participants Assessed for Adverse Events

  Participants were followed during treatment and for 30 days after completion of treatment

• Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy

  1 month after completion of treatment

• Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.

  One month post-therapy

• Disease-Free Survival After Therapy

  Five years post treatment

• Overall Length of Survival After Therapy

  Five years post treatment

Study Arms (1)

Cetuximab, Gemcitabine, RT

EXPERIMENTAL

weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

Drug: Cetuximab/Gemcitabine; Procedure: Radiotherapy

Interventions

Cetuximab/Gemcitabine DRUG

Once weekly Cetuximab, twice weekly Gemcitabine for six weeks

Also known as: Erbitux

Cetuximab, Gemcitabine, RT

Radiotherapy PROCEDURE

Daily radiotherapy for 28 days

Cetuximab, Gemcitabine, RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic proof of pancreatic adenocarcinoma
• Clinical stage I, II, or III disease
• Radiographically measurable disease
• Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
• Signed protocol consent
• Karnofsky performance status of at least 70%
• Age \> or = to 18 years
• Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
• Absolute neutrophil count (ANC) \> 1500; platelets \> 100,000/ul.
• Creatinine \< 1.5 x upper limit of normal (ULN)
• Bilirubin \< 1.5 x ULN; AST \< 2.5 x ULN.

You may not qualify if:

• Acute hepatitis or known HIV
• Active or uncontrolled infection
• Significant history of cardiac disease
• Prior therapy which affects or targets the EGF pathway
• Prior severe infusion reaction to a monoclonal antibody
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
• Any previous chemotherapy or abdominal or pelvic radiotherapy
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
• Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Gemcitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Limitations and Caveats

Our study suffers limitations common to single institution trials, namely small patient numbers and selection bias. Our cohort of subjects is too small to adequately assess the effect of tumor EGFR and KRAS status on outcome.

Results Point of Contact

• Title: J. Marc Pipas, MD
• Organization: Dartmouth-Hitchcock

J.Marc.Pipas@hitchcock.org

603-650-9474

Study Officials

• J Marc Pipas, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2012
• Last Updated: July 16, 2014
• Results First Posted: April 18, 2013

Record last verified: 2011-10