L-glutamine + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJun Gong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Jun Gong, MD

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will enroll a total of 16 patients with advanced pancreatic cancer at Cedars-Sinai Medical Center. All subjects will receive combination therapy of gemcitabine, nab-paclitaxel, and L-glutamine. The study investigates what the appropriate dosage of L-glutamine is so that there is the lowest risk of side effects, and whether the supplement will make standard chemotherapy of gemcitabine and nab-paclitaxel more effective in treating advanced pancreatic cancer.

Eligibility Criteria

Adults with advanced pancreatic cancer who haven't had chemotherapy for metastatic disease can join. They must have good organ function, not be pregnant or breastfeeding, agree to use birth control, and be able to follow the study plan. People with severe pre-existing neuropathy, other active cancers, or conditions that could affect the study's outcome cannot participate.

Inclusion Criteria

You have a disease that can be measured using a specific standard.

I can take care of myself but might not be able to do heavy physical work.

My pancreatic cancer is advanced or cannot be surgically removed and I am referred to CSMC/SOCCI for first chemotherapy.

+7 more

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I haven't taken strong CYP2C8 or CYP3A4 drugs in the last week.

I have another cancer that is getting worse or needs treatment.

+9 more

Participant Groups

The trial is testing a combination of gemcitabine and nab-paclitaxel with L-glutamine in patients at Cedars-Sinai Medical Center. It aims to find the safest dose of L-glutamine and see if it boosts the effectiveness of standard chemotherapy in treating advanced pancreatic cancer.

1Treatment groups

Experimental Treatment

Group I: Gemcitabine + Nab-paclitaxel + L-glutamineExperimental Treatment3 Interventions

For the dose-finding portion of this study, all subjects will receive a combination of L-glutamine, gemcitabine, and nab-paclitaxel which will be preceded by a 1-week (+/- 1 day) administration of L-glutamine. This 1-week administration of L-glutamine will facilitate measurement of baseline and post-glutamine monotherapy plasma metabolite levels prior to addition of gemcitabine and nab-paclitaxel. The combination therapy will be administered over 28-day cycles during the treatment period until disease progression, treatment intolerance, or withdrawal from the study. Patients are expected to be on treatment for 12 cycles.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: