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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2005141 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20052717 | Other Identifier | Western Insitutional Review Board |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, pilot study.
Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2-4 hours on day 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| |
| Gemcitabine Hydrochloride | Drug | Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles. |
| |
| Oxaliplatin | Drug | Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The response rate will be determined by the RECIST criteria. After every 4th cycle; End of Treatment and Follow-up |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic cancer
Locally advanced or metastatic disease
No active CNS metastases
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Caio Max S. Rocha Lima, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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, taking as reference for PD the smallest measurements recorded since the treatment started | 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. | 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, taking as reference the smallest measurements recorded since the treatment started (also referred to in the RECIST criteria as duration of stable disease). | The time from the start of the treatment until the criteria for disease progression are met |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |