CLINICAL TRIAL

L-glutamine for Cancer of Pancreas

Recruiting · 18+ · All Sexes · Beverly Hills, CA

This study is evaluating whether a supplement may help improve the effectiveness of chemotherapy for pancreatic cancer.

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About the trial for Cancer of Pancreas

Eligible Conditions
Adenocarcinoma · Pancreatic Neoplasms · Malignant Neoplasm of Pancreas · Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) · Advanced Pancreatic Adenocarcinoma

Treatment Groups

This trial involves 2 different treatments. L-glutamine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nab-paclitaxel
DRUG
L-glutamine
DRUG
Gemcitabine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
L-Glutamine
FDA approved
Gemcitabine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer of Pancreas or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are female and have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication show original
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. show original
Advanced or unresectable, histologically confirmed pancreatic cancer (new diagnosis or recurrent) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI) for first-line chemotherapy. Prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation is allowed but must have been completed >12 months prior to recurrence.
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 or Karnofsky performance status ≥60%
Demonstrate adequate organ and marrow function (within 14 days of study treatment initiation)
You have measurable disease based on RECIST 1.1. show original
Female subjects of childbearing potential should be willing to use adequate methods of birth control (hormonal or barrier method of birth control) or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Willingness to undergo serial peripheral blood draws and provide stool samples during predefined study timepoints and under prespecified conditions (i.e., fasted, morning blood collections).
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From screening/baseline until the last dose of study treatment (up to approximately 12 months).
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From screening/baseline until the last dose of study treatment (up to approximately 12 months)..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether L-glutamine will improve 1 primary outcome and 4 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 4 weeks.

Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer.
4 WEEKS
The number of dose-limiting toxicities (DLTs), defined as the rate of drug-related grade ≥3 adverse events (AEs) experienced within the first 4 weeks (1 cycle) of study treatment. The RP2D is defined as the dose level closest to the median of the posterior distribution of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of DLT at the MTD is θ=0.33.
Describe the safety of gemcitabine, nab-paclitaxel and L-glutamine across all investigated dose levels in subjects with untreated advanced pancreatic cancer
FROM FIRST DOSE OF STUDY TREATMENT UNTIL 30 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 12 MONTHS)..
Number of adverse events as assessed by NCI CTCAE version 5.0
Describe any preliminary evidence of antitumor activity of the combination by assessment of objective response rate as determined by RECIST 1.1 criteria in patients with measurable disease.
FROM SCREENING/BASELINE UNTIL THE LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 12 MONTHS).
Clinical activity of the combination including objective response rate (ORR), defined as proportion of patients with confirmed PR or CR, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1)
Describe any preliminary evidence of antitumor activity of the combination by assessment of overall survival as determined by RECIST 1.1 criteria in patients with measurable disease.
FROM SCREENING/BASELINE UNTIL THE LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 12 MONTHS).
Clinical activity of the combination including overall survival (OS), defined as from baseline until date of death due to any cause, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1).
Describe any preliminary evidence of antitumor activity of the combination by assessment of progression-free survival as determined by RECIST 1.1 criteria in patients with measurable disease.
FROM SCREENING/BASELINE UNTIL THE LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 12 MONTHS).
Clinical activity of the combination including progression-free survival (PFS), defined as from baseline until date of progression or death due to any cause, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1).

Patient Q & A Section

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

How many people get cancer of pancreas a year in the United States?

One third of patients with [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) are over 70 years of age, and cancer of the pancreas is a debilitating and often lethal disease that can afflict any age group.

Anonymous Patient Answer

What are the signs of cancer of pancreas?

Signs of pancreatic cancer can include weight loss, an abrupt decrease in blood sugar or a decrease in the white blood cell count. Pain in the upper part of the abdomen may also be a sign of pancreatic cancer. Pain in the back and stomach may be a sign of pancreatitis.

Anonymous Patient Answer

What is cancer of pancreas?

Cancer of pancreatic is one of the 10 most common cancer of Western countries and can develop in all demographics. Pancreas is one of the five most common sites of gastrointestinal cancer, with pancreatic cancer accounting for less than 5% of the total number of gastrointestinal cancer cases. It is the 9th most common cause of cancer related death in United Kingdom.

Anonymous Patient Answer

What causes cancer of pancreas?

If the body produces harmful chemicals or if it doesn't get enough nutrients, then it may eventually develop cancer of pancreas. \n\nThe most common cause of pancreatic cancer is chronic smoking of cigarettes. Other common cancer causing factors are stomach pain due to gallstones, alcohol consumption, diabetes, chronic pancreatitis, family history of pancreatic cancer, chronic pancreatitis due to chronic pancreatitis of unknown cause, gallstones due to chronic pancreatitis and excess alcohol intake. It is thought that this cancer is caused by the overproduction of enzymes that damage the pancreas.

Anonymous Patient Answer

What are common treatments for cancer of pancreas?

Pancreatic cancer is commonly treated with either chemotherapy or surgery. Chemotherapy combines the benefits of surgery with the adverse effects of chemotherapy, often producing long-lasting remission before the development of disease progression or metastasis.

Anonymous Patient Answer

Can cancer of pancreas be cured?

When cancer of pancreas is localized and the tumour has a low mitotic rate, surgery is the treatment of choice. However, it is possible for cancer cells from pancreatic cancer to travel outside the pancreas and form a metastatic lesion. The use of targeted therapy is the key for a cure.

Anonymous Patient Answer

What is the latest research for cancer of pancreas?

At this point of time, we have little information to support our current treatment protocols for [pancreas cancer](https://www.withpower.com/clinical-trials/pancreas-cancer). We have more opportunities for prevention of this devastating cancer.

Anonymous Patient Answer

How serious can cancer of pancreas be?

In Poland serious form of cancer of pancreas is quite rare, however, pancreatobiliary system is a very important organ in the body that could be harmed by pancreatic tissue and cancer.

Anonymous Patient Answer

What are the common side effects of l-glutamine?

L-glutamine is safe and effective in reducing grade 2-3 chronic diarrhea and grade 1-2 oral ulcers. The GI side effects can be controlled at least in part by appropriate prescription.

Anonymous Patient Answer

Has l-glutamine proven to be more effective than a placebo?

Compared with a placebo, oral l-glutamine has a significant and more rapid effect in patients with advanced inoperable gastric cancer who have already been administered an oxaliplatin-based chemotherapy regimen.

Anonymous Patient Answer

Does cancer of pancreas run in families?

Results from a recent clinical trial of study suggests that patients with family history of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) have significant risk of developing pancreatic cancer and also pancreatic divisiveness, especially in those with a history of a family member with the early age. Further, patients with cancer of pancreas usually present with some digestive disorders. Therefore, it is advised to perform early diagnosis for patients with a family history of pancreas cancer, and initiate the appropriate treatments at the time when the patient is diagnosed with pancreatic cancer.

Anonymous Patient Answer
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