Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Pancreatic Adenocarcinoma Protocol

Part of paid clinical trials in New York, New York.

Sponsor
Beth Israel Medical Center
Study ID
NCT01760252
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than other combinations used to treat earlier stage pancreatic cancer patients with resectable (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma. For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by the FDA, their combination is investigational. The purpose of this study is to evaluate the effects of CAPOXIRI (good and bad) on you and your cancer.

Key Dates

Start date
Dec 31, 2011
Status verified
Mar 2019
Primary completion
Feb 21, 2018
Completion
Feb 21, 2018

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CAPOXIRI Chemotherapy Regimen
    Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI) The proposed chemotherapy regimen CAPOXIRI is: * Capecitabine 1000mg/m2 p.o. bid on days 1-7 * Oxaliplatin 85mg/m2 intravenously (IV) on day 1 * Irinotecan 150mg/m2 IV on day 1

Primary Outcome Measure

The primary end point is the treatment adherence rate (TAR) which is the percentage of patients who complete 75% of the planned treatment (dose) for their diagnostic strata (resectable disease and borderline resectable/locally advanced disease) [ Time Frame: 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Comprehensive Care CenterNew YorkNew York10025-
Mount Sinai Beth IsraelNew YorkNew York10003-
St-Lukes Roosevelt Hospital Medical CenterNew YorkNew York10018-

Find similar trials in New York, NY

By research site
Beth Israel Comprehensive Care Center· New York, NYMount Sinai Beth Israel· New York, NYSt-Lukes Roosevelt Hospital Medical Center· New York, NY

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