Clinical trialEPhase 1Terminated
Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas
- Outcome
- Stopped earlyStudy terminated due to low accrual (Enrollment)
- Phase
- EPhase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2012
- Enrollment
- 2 participants
- Sites
- 1
- Primary outcomes
- Tumor Response
- Sponsor
- Other
- Results posted
- 2015-11-09
- Last update
- 8 March 2016
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Brief summary public domain (ClinicalTrials.gov)
This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study.
Detailed description public domain (ClinicalTrials.gov)
If subjects are eligible and wish to enroll in the study, they will begin chemotherapy treatment with Gemcitabine and Abraxane. After subjects have received treatment with these drugs, they will have surgery. Subjects will also have post treatment and follow up evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects will be followed every 3 months for 3 years after their initial registration.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tumor Response [at time of surgery].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With R0 Resection Status. [at time of surgery]. Number, participants. Chemotherapy, Surgery (n=2): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Estimate Median Time to Recurrence. [2 years]. Number, days. Chemotherapy, Surgery (n=1): 329.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Estimate Median Overall Survival [2 years]. Number, days. Chemotherapy, Surgery (n=1): 465.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Adverse Events Reported in Subjects Enrolled. [First study drug administration until end of study]. Number, adverse events. Chemotherapy, Surgery (n=2): 60.