75 Participants Needed

Adjuvant Chemotherapy for Pancreatic Cancer

Recruiting at 8 trial locations
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Howard S. Hochster, MD, FACP | Rutgers ...
Overseen ByHoward S. Hochster
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Primary Objectives: To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone. Secondary Objectives: To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS). To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates. To assess the quality of life in patients receiving the study treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any investigational agents at the time of registration.

What data supports the idea that Adjuvant Chemotherapy for Pancreatic Cancer (also known as: Capecitabine, Xeloda, Gemcitabine, Gemzar) is an effective treatment?

The available research shows that using a combination of the drugs gemcitabine and capecitabine (GEMCAP) is more effective than using gemcitabine alone for treating pancreatic cancer. In a study, patients who received GEMCAP lived longer, with a median survival of 31.4 months compared to 22.1 months for those who only received gemcitabine. This suggests that GEMCAP is a more effective treatment option for pancreatic cancer.12345

What safety data exists for adjuvant chemotherapy in pancreatic cancer?

Safety data for adjuvant chemotherapy in pancreatic cancer includes studies on capecitabine (Xeloda) and gemcitabine (Gemzar). Capecitabine has been evaluated for safety in patients with advanced pancreatic cancer. Gemcitabine, alone and in combination with capecitabine, has been studied in various trials, showing potential benefits but also side effects like myelotoxicity, nausea, and vomiting. The combination of gemcitabine and capecitabine (GemCap) has been shown to improve overall survival compared to gemcitabine alone, with safety evaluations conducted in different populations.36789

Is the drug used in the trial 'Adjuvant Chemotherapy for Pancreatic Cancer' a promising treatment?

Yes, the drug gemcitabine, used in the trial, is considered promising for pancreatic cancer. It has shown benefits like pain reduction and improved quality of life. It is also being tested in combination with other drugs to enhance its effectiveness.410111213

Research Team

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Prateek Gulhati, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults with pancreatic cancer who've had neoadjuvant chemotherapy and surgery to remove the tumor. They should be in fair to good physical condition, have normal blood counts and organ function, and agree to use birth control. People can't join if they're pregnant, have severe liver problems, other active cancers or major illnesses that could interfere with the study.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.
My blood tests show my organs and bone marrow are working well.
I am 18 years old or older.
See 11 more

Exclusion Criteria

Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study
My scans show cancer has spread or I have fluid buildup due to cancer.
Pregnancy
See 9 more

Treatment Details

Interventions

  • Capecitabine
  • Gemcitabine
Trial OverviewThe trial tests whether adding Gemcitabine and Capecitabine chemotherapy after surgery improves disease-free survival compared to just having neoadjuvant therapy before surgery. It also looks at overall survival rates, side effects, and quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1- Gemcitabine and Capecitabine TreatmentExperimental Treatment1 Intervention
Day 1, Day 8, Day 15 • Gemcitabine infused through a vein over 120 minutes Day 1 - Day 21 • Capecitabine tablets will be taken two times a day; once in the morning and once in the evening. The tablets should not be crushed or split and should be taken with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal.
Group II: Group 2 - ObservationalActive Control1 Intervention
Usual therapy used to treat this type of cancer, chemotherapy plus radiation therapy. If cancer returns during observation, there will be offered standard of care therapy. Follow-up visits will be every three months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Findings from Research

In a study of 778 patients with pancreatic ductal adenocarcinoma, adjuvant chemotherapy with gemcitabine plus capecitabine (GEMCAP) resulted in significantly better overall survival (31.4 months) compared to gemcitabine monotherapy (22.1 months).
The survival benefit of GEMCAP remained significant even after adjusting for various prognostic factors, indicating that it may be a more effective treatment option for patients ineligible for more intensive therapies.
Real-world evidence of adjuvant gemcitabine plus capecitabine vs gemcitabine monotherapy for pancreatic ductal adenocarcinoma.de Jong, EJM., Janssen, QP., Simons, TFA., et al.[2023]
In a study of 53 patients with inoperable or metastatic pancreatic cancer, the combination of gemcitabine (GEM) and capecitabine (CAP) resulted in an 18.9% rate of objective partial responses and a median overall survival of 8 months, indicating its potential efficacy as a treatment option.
The treatment was generally well tolerated, with 53% of patients experiencing pain improvement and 36% showing weight gain, while serious side effects like grade 3 anemia and neutropenia were relatively low, suggesting a favorable safety profile.
Front-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II study.Stathopoulos, GP., Syrigos, K., Polyzos, A., et al.[2022]
In a phase III trial involving 214 patients with advanced pancreatic cancer, the combination of gemcitabine and capecitabine (GemCap) showed a trend towards improved overall survival (10.3 months) compared to gemcitabine alone (7.5 months), although this difference was not statistically significant (P=0.06).
GemCap significantly increased the overall response rate (43.7% vs 17.6%, P=0.001) compared to single-agent gemcitabine, while both treatment regimens had similar safety profiles, with neutropenia being the most common severe toxicity.
A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line chemotherapy for advanced pancreatic cancer in South Korea.Lee, HS., Chung, MJ., Park, JY., et al.[2022]

References

Real-world evidence of adjuvant gemcitabine plus capecitabine vs gemcitabine monotherapy for pancreatic ductal adenocarcinoma. [2023]
Front-line treatment of inoperable or metastatic pancreatic cancer with gemcitabine and capecitabine: an intergroup, multicenter, phase II study. [2022]
A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line chemotherapy for advanced pancreatic cancer in South Korea. [2022]
Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival? [2022]
FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. [2023]
Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. [2022]
Real-world outcomes of adjuvant gemcitabine versus gemcitabine plus capecitabine for resected pancreatic ductal adenocarcinoma. [2022]
[Compassionate use of gemcitabine in advanced pancreatic cancer: a French multicentric study]. [2022]
Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial. [2022]
Gemcitabine in the treatment of metastatic pancreatic cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A randomized phase II trial of adjuvant chemotherapy with uracil/tegafur and gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. [2022]
The combination of a chemotherapy doublet (gemcitabine and capecitabine) with a biological doublet (bevacizumab and erlotinib) in patients with advanced pancreatic adenocarcinoma. The results of a phase I/II study. [2022]