PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca

NCT00467116 | Completed Phase 1 DMC

• 2 other identifiers: VICC GI 0466VU-VICC-GI-0466
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with cetuximab and radiation therapy in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Weekly and 4 weeks after last dose of radiation

Secondary Outcomes (3)

• Dose-limiting toxicity

  Weekly and 4 weeks after last dose of radiation

• Toxicity

  Weekly and 4 weeks after last dose of radiation

• Tumor response rate

  4 weeks after last dose of radiation and every 3 months

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Biological: cetuximab; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

Interventions

cetuximab BIOLOGICAL

400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.

Also known as: Erbitux

Therapeutic Intervention

gemcitabine hydrochloride DRUG

Dose Level Gemcitabine dose Gemcitabine infusion -1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes 1. 300mg/m2 30 minutes 2. 400mg/m2 40 minutes

Also known as: Gemzar

Therapeutic Intervention

radiation therapy RADIATION

50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm. The prescription point will be designated at the intersection of the multiple beams. There are no planned interruptions \> 3 days.

Therapeutic Intervention

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria:
• Unresectable disease
• Locally advanced disease
• Measurable or evaluable disease by CT scan or MRI
• No evidence of metastatic disease outside of the planned irradiation field
• ECOG performance status 0-2
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.5 g/dL
• AST and ALT ≤ 5 times upper limit of normal
• Bilirubin ≤ 2.0 mg/dL
• Creatinine ≤ 2.0 mg/dL
• No clinical indication of compromised function of nonirradiated kidney
• No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix

You may not qualify if:

• No acute hepatitis
• No known HIV infection
• No other active or uncontrolled infection
• No significant history of uncontrolled cardiac disease, including any of the following:
• Hypertension
• Unstable angina
• Myocardial infarction within the past 6 months
• Congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• No prior severe infusion reaction to a monoclonal antibody
• PRIOR CONCURRENT THERAPY:
• No prior radiotherapy to planned field of treatment
• No prior therapy that specifically and directly targets EGFR pathway
• At least 14 days since prior surgery or biopsy
• At least 28 days since prior bypass procedures

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

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

Study Officials

• Nipun B. Merchant

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Cancer Biology; Gastrointestinal Surgical Oncologist

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: October 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

US (1)