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Gemcitabine Hydrochloride for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Gauri R Varadhachary
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be willing and able to provide written informed consent for the trial
Patients must have potentially resectable pancreatic carcinoma and have agreed to undergo surgical resection at Monroe Dunaway (MD) Anderson Cancer Center if operable; they will have undergone staging (physical examination, contrast enhanced computed tomography [CT] or magnetic resonance imaging [MRI] [if CT contraindicated] to determine resectability)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab, paricalcitol, and chemotherapy as a possible treatment for pancreatic cancer before surgery.

Eligible Conditions
  • Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of toxicities as defined by Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Resection rate
Other outcome measures
Disease free survival (DFS)
Overall survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (pembrolizumab, paricalcitol, chemotherapy)Experimental Treatment6 Interventions
Patients receive pembrolizumab and paricalcitol as in Arm A. Patients also receive gemcitabine hydrochloride IV over 30 minutes and nab-paclitaxel IV over 30-40 minutes on days 1, 8, and 15 of course 1 in the absence of disease progression or unacceptable toxicity. Surgical resection is performed within 1 week and up to 4 weeks from last dose of paricalcitol.
Group II: Arm A (pembrolizumab, paricalcitol)Active Control4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 of each course and paricalcitol IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Surgical resection is performed within 1 week and up to 4 weeks from last dose of paricalcitol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Nab-paclitaxel
2014
Completed Phase 3
~2030
Paricalcitol
2013
Completed Phase 4
~1730
Pembrolizumab
2017
Completed Phase 2
~1950
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,330 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,266 Total Patients Enrolled
Gauri R VaradhacharyPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on the number of participants in this clinical evaluation?

"This trial is not actively recruiting participants. It was first listed on February 20th 2017 and last updated September 22nd 2022. If you're looking for alternatives, there are currently 580 trials specifically seeking patients with pancreatic carcinoma and 1981 studies enrolling those interested in receiving Pembrolizumab treatment."

Answered by AI

Are there currently vacancies available for participants of this trial?

"The latest update on clinicaltrials.gov reveals that this medical trial is not presently recruiting patients; it was initially posted in February of 2017 and its last modification occurred in September 2022. Nonetheless, there are over two-thousand five hundred sixty one other studies actively seeking participants at the present moment."

Answered by AI

Has Pembrolizumab received the regulatory stamp of approval from the FDA?

"The safety of Pembrolizumab is estimated to be a 1, as the current trial stage only provides minimal data supporting its efficacy and security."

Answered by AI

What is the primary condition that Pembrolizumab has been shown to alleviate?

"Pembrolizumab is a commonly-prescribed medication for mesotheliomas and other diseases, such as metastatic esophageal carcinoma, hemodialysis, or advanced soft tissue sarcoma."

Answered by AI

Are there any antecedent investigations related to Pembrolizumab?

"Currently, there are 1981 Pembrolizumab-focused trials occurring worldwide. Of those studies, 415 of them have reached the third phase and can be found in Shanghai as well as 85517 other locations."

Answered by AI
~1 spots leftby Mar 2025