Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

NCT00408564 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000518313MUSC-100918BMS-MUSC-100918SANOFI-MUSC-100918
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival at 6 Months

  up to 46 weeks after the start of study treatment

Secondary Outcomes (5)

• Number of Participants With Grade 3-4 Adverse Events Reported

  from start of study treatment until end of study visit, about 30 weeks

• Overall Survival

  up to 46 weeks after the start of study treatment

• Response Rate

  up to 46 weeks after the start of study treatment

• Response Duration in Patients With at Least Partial Response to Treatment

  up to 46 weeks after the start of study treatment

• Determine the Biomarker Response of CA 19-9 to Therapy

  from start up treatment to one year after end of treatment, up to 81 weeks

Study Arms (1)

Gemcitabine,Oxaliplatin and Cetuximab

EXPERIMENTAL

Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks. After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.

Biological: cetuximab; Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Radiation: radiation therapy; Drug: Gemcitabine

Interventions

cetuximab BIOLOGICAL

Gemcitabine,Oxaliplatin and Cetuximab

capecitabine DRUG

Gemcitabine,Oxaliplatin and Cetuximab

oxaliplatin DRUG

Gemcitabine,Oxaliplatin and Cetuximab

conventional surgery PROCEDURE

Gemcitabine,Oxaliplatin and Cetuximab

radiation therapy RADIATION

Gemcitabine,Oxaliplatin and Cetuximab

Gemcitabine DRUG

Gemcitabine,Oxaliplatin and Cetuximab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria: * Locally advanced, nonmetastatic disease * Surgically unresectable disease * Measurable disease, defined as unidimensionally measurable by physical exam or imaging study * The following are considered nonmeasurable disease: * Bone-only disease * Pleural or peritoneal effusions * CNS lesions * Irradiated lesions in the absence of progression after radiotherapy * No history or evidence of CNS disease * No metastatic disease to distant organs (e.g., liver, lung, brain, or bone) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy * No acute hepatitis * No known HIV positivity * No active or uncontrolled infection * No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following: * Uncontrolled hypertension * Unstable angina * Myocardial infarction within the past 6 months * Uncontrolled congestive heart failure * Cardiomyopathy with decreased ejection fraction * No prior severe infusion reaction to a monoclonal antibody * No active second malignancy other than nonmelanoma skin cancer * No history of deep vein thrombosis * No history of bleeding diathesis or coagulopathy * No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: * No prior therapy for pancreatic cancer * No prior therapy specifically targeting the epidermal growth factor-receptor pathway * No major surgical procedure or open biopsy within the past 28 days * No prior radiotherapy or chemotherapy * No prior or concurrent full-dose anticoagulants or thrombolytics

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Capecitabine; Oxaliplatin; Radiotherapy; Gemcitabine

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Kate Anderton, MPH, CCRP
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Andrew S. Kraft, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

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: December 6, 2006
• First Posted: December 7, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 23, 2018
• Results First Posted: July 23, 2018

Record last verified: 2018-05

Locations

US (1)