Status:
COMPLETED
Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
Lead Sponsor:
Yale University
Conditions:
Metastatic Pancreatic Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancr...
Detailed Description
A phase II open label single arm multi-institutional study at Yale's Smilow Cancer Hospital (New Haven, CT, USA), the Smilow Cancer Hospital Care Centers (regional community-based clinics), the VA Con...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pathologic or cytologic documentation of pancreatic adenocarcinoma
- Metastatic or locally advanced unresectable disease, including borderline unresectable disease
- Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
- Measurable or non-measurable assessable disease
- No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
- 6 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
- No prior treatment with oxaliplatin or irinotecan
- No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
- Patients who received chemotherapy \> 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed \> 2 years ago and there is no evidence of the second malignancy at the time of study entry
- \> 4 weeks since major surgery
- No other concurrent anticancer therapy
- ECOG Performance Status: 0-1
- Age \> 18
- No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
- Paraffin block or slides must be available
- Adequate organ function
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- No \> grade 1 sensory peripheral neuropathy
- No uncontrolled seizure disorder, active neurological disease, or known CNS disease
- No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
- No history of chronic diarrhea
- Not pregnant and not nursing
- No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
- Laboratory parameters as follows: absolute neutrophil count ≥ 1,500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9 g,/dL, creatinine \< 1.5 X ULN or estimated GFR \> 30 ml/min, bilirubin \< 1.5 X ULN, AST and ALT \< 3 X ULN, negative pregnancy test in women of childbearing age
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01523457
Start Date
October 1 2011
End Date
December 1 2015
Last Update
August 30 2017
Active Locations (1)
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1
Smilow Cancer Center
New Haven, Connecticut, United States, 06510