Clinical trialPhase 2Completed
Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- October 2011
- Expected end
- December 2015
- Enrollment
- 75 participants
- Sites
- 1
- Primary outcomes
- Progression Free Survival
- Sponsor
- Other
- Results posted
- 2017-08-30
- Last update
- 30 August 2017
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Brief summary public domain (ClinicalTrials.gov)
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 pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using \[18F\]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.
Detailed description public domain (ClinicalTrials.gov)
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 Connecticut Healthcare System West Haven Campus (West Haven, CT, USA) and Bridgeport Hospital (Bridgeport, CT, USA). The primary objective of this study was to determine the PFS in patients with MPC and LAPC treated with a dose attenuated modification of FOLFIRINOX. NOTE: Upon results reporting (2016), the registration record was reorganized to display MPC and LAPC groups in individual arms. The most meaningful comparison is between MPC/LAPC and historical controls. That is how results are reported in the published paper, see citations.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [24 weeks]. Number, percentage of participants. MPC Modified FOLFIRINOX (n=37): 54; LAPC Modified FOLFIRINOX (n=29): 97.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate [24 weeks]. Number, percentage of participants. MPC Modified FOLFIRINOX (n=37): 35.1; LAPC Modified FOLFIRINOX (n=29): 17.2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [24 weeks]. Number, percentage of participants. MPC Modified FOLFIRINOX (n=37): 81; LAPC Modified FOLFIRINOX (n=29): 100.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicity [24 weeks]. Number, participants. Neutropenia: MPC Modified FOLFIRINOX (n=43): 4; LAPC Modified FOLFIRINOX (n=31): 5. Thrombocytopenia: MPC Modified FOLFIRINOX (n=43): 5; LAPC Modified FOLFIRINOX (n=31): 2. Anaemia: MPC Modified FOLFIRINOX (n=43): 2; LAPC Modified FOLFIRINOX (n=31): 2. Febrile neutropenia: MPC Modified FOLFIRINOX (n=43): 1; LAPC Modified FOLFIRINOX (n=31): 2. Diarrhea: MPC Modified FOLFIRINOX (n=43): 8; LAPC Modified FOLFIRINOX (n=31): 4. Fatigue: MPC Modified FOLFIRINOX (n=43): 5; LAPC Modified FOLFIRINOX (n=31): 4. Alanine aminotransferase (ALT) increased: MPC Modified FOLFIRINOX (n=43): 3; LAPC Modified FOLFIRINOX (n=31): 0. Thromboembolic event: MPC Modified FOLFIRINOX (n=43): 3; LAPC Modified FOLFIRINOX (n=31): 0. Peripheral sensory neuropathy: MPC Modified FOLFIRINOX (n=43): 2; LAPC Modified FOLFIRINOX (n=31): 0. Vomiting: MPC Modified FOLFIRINOX (n=43): 1; LAPC Modified FOLFIRINOX (n=31): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Rate of Resection in Patients With Locally Advanced Disease [24 weeks]. Number, participants. Total: LAPC Modified FOLFIRINOX (n=31): 13. Unresectable: LAPC Modified FOLFIRINOX (n=31): 6. Borderline: LAPC Modified FOLFIRINOX (n=31): 7.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning [24 weeks].
Papers 1
- Registry-listed results paperFinal analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. DOI 10.1038/bjc.2016.45↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.