Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT00448838 | Completed DMC

• 3 other identifiers: 20057548SCCC-2005141WIRB-20052717
• Study Type: interventional
• Target: 42
• 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. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method

  The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals

Secondary Outcomes (5)

• Toxicity

  Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.

• Response rate (complete response and partial response)

  After every 4th cycle; End of Treatment and Follow-up

• Duration of response

  The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented

• Overall survival

  Overall survival will also be estimated using the product-limit method of Kaplan-Meier.

• Time to progression

  The time from the start of the treatment until the criteria for disease progression are met

Interventions

Cetuximab BIOLOGICAL

Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.

Also known as: C-225

Gemcitabine Hydrochloride DRUG

Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.

Also known as: Gemcitabine HCl

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic cancer * Locally advanced or metastatic disease * No active CNS metastases * Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for \> 3 weeks, are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases) * AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 90 days after completion of study treatment * No significant history of uncontrolled cardiac disease, including 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 infection or fever ≥ 38.5°C within the past 3 days * No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody * No peripheral neuropathy ≥ grade 2 * No known HIV positivity * No hepatitis B or C infection (active, previously treated, or both) * No other medical condition, including mental illness or substance abuse, that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy, including surgery * More than 30 days since prior investigational therapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * More than 30 days since prior chemotherapy * No prior chemotherapy for metastatic pancreatic cancer * Prior fluoropyrimidine as a radiosensitizer allowed * Prior gemcitabine hydrochloride in the adjuvant setting allowed * No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway * No prior allogeneic transplantation * No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy * No other concurrent treatment that targets the EGFR * No other concurrent monoclonal antibody therapy * No concurrent radiotherapy except for local control of bone pain

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Gemcitabine; Oxaliplatin

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; Coordination Complexes; Organic Chemicals

Study Officials

• Caio Max S. Rocha Lima, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: March 1, 2011
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)