Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
This trial is active, not recruiting.
|Treatments||oxaliplatin, 5fu, radiation, surgery, folfox 6|
|Phase||phase 1/phase 2|
|Sponsor||New York University School of Medicine|
|Start date||June 2004|
|End date||July 2010|
|Trial size||24 participants|
|Trial identifier||NCT00463840, 03-64, H11640, Sanofi-Aventis 0x 03-030|
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Resectability After Chemoradiation
time frame: 7.5 weeks
Median Overall Survival
time frame: up to 10 years since the start of the study
Male or female participants at least 18 years old.
Inclusion Criteria: - Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs - Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator. - No prior chemotherapy or abdominal radiation therapy. - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - Clinically measurable or evaluable disease. - Life expectancy of at least 12 weeks. - Adequate bone marrow reserve, granulocyte count >= 1500/uL, platelet count >= 100,000/uL, hemoglobin >= 9 g/dL. - Adequate renal function with creatinine =< 1.5 times upper limit of normal (ULN) - Adequate biliary function with bilirubin < 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =< 2.5 - Age > 18 years - Signed informed consent. - No known allergy to one of the study drugs - For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception - No prior malignancy within last 5 years - No central nervous system metastases - No peripheral neuropathy > grade2 - No other serious concomitant illness Exclusion Criteria: - Active infection or uncontrolled infection - Presence of metastatic disease. - Inadequate organ function as discussed above. - Pregnancy - Serious concomitant systemic disorder. - Use of any investigational agent within a month of treatment
|Official title||A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer|
|Principal investigator||Theresa Ryan, MD|
|Description||Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine. In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.|
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