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Completed

NCT Number: NCT00225784

Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The study treatment for this protocol is

  • Loading dose of Cetuximab 400 mg/m2
  • Weekly Cetuximab 250 mg/m2
  • Bi-weekly Gemcitabine 50 mg/m2
  • Daily Radiation for 28 fractions
  • CT scan four weeks after completion of treatment
  • Evaluation by surgeon for resectability

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cetuximab/Gemcitabine

Drug

Once weekly Cetuximab, twice weekly Gemcitabine for six weeks

Other names: Erbitux

Radiotherapy

Procedure

Daily radiotherapy for 28 days

Primary outcomes

  1. Objective Response of Tumor by RECIST 1.0 Criteria

    Time frame: one month post-therapy

    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.

Secondary outcomes

  1. Number of Participants Assessed for Adverse Events

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

    Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0

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

    Time frame: 1 month after completion of treatment

    Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).

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

    Time frame: One month post-therapy

    Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.

  4. Disease-Free Survival After Therapy

    Time frame: Five years post treatment

    Time to disease progression after therapy.

  5. Overall Length of Survival After Therapy

    Time frame: Five years post treatment

    Length of survival after therapy in all participants enrolled.

  6. Pattern of Failure After Therapy

    Time frame: Five years post treatment

    Local recurrence, distant recurrence, or both.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Sep 26, 2005
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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