Adjuvant Chemotherapy for Pancreatic Cancer

Not currently recruiting at 8 trial locations

Overseen By Howard S. Hochster

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Investigational agents

Disqualifiers: Brain metastases, Metastatic disease, Neuropathy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of chemotherapy drugs, Capecitabine (Xeloda) and Gemcitabine (Gemzar), for individuals who have undergone pancreatic cancer surgery. The researchers aim to determine if these drugs can help patients remain cancer-free longer compared to the usual therapy. The trial also evaluates the safety and tolerability of the treatment and its impact on patients' quality of life. Suitable candidates have had pancreatic cancer surgery and received chemotherapy before surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of two drugs, gemcitabine and capecitabine (often called GemCap), has been studied for treating pancreatic cancer. Studies have found that this combination can help patients live longer compared to using gemcitabine alone. Researchers have examined how well patients tolerate these drugs together.

Previous findings suggest that while these drugs can extend life for some patients, they may also cause side effects. Common side effects include fatigue, nausea, and low blood cell counts, which can increase infection risk. However, these side effects vary among individuals, and not everyone will experience them.

In this trial, researchers will closely monitor safety and how well patients manage the treatment. Participants will have regular check-ins to help manage any side effects they might experience. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Capecitabine and Gemcitabine for pancreatic cancer because it offers a potential improvement over standard treatments. Unlike traditional chemotherapy, which may use different drugs, this combination uses Capecitabine, an oral medication that patients can take at home, allowing for more convenience compared to intravenous-only treatments. Gemcitabine, infused through a vein, has shown effectiveness in attacking cancer cells and, when paired with Capecitabine, might enhance the overall treatment impact by targeting cancer in a complementary way. This dual approach could potentially offer better outcomes by combining the strengths of both oral and intravenous chemotherapy.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that combining the drugs gemcitabine and capecitabine can improve outcomes for people with pancreatic cancer. In this trial, participants in Group 1 will receive this combination treatment. For those who undergo surgery followed by this chemotherapy mix, the chance of living for five years can reach up to 30%. This combination has also increased the one-year survival rate by about 20% for those with advanced pancreatic cancer. In some cases, adding capecitabine to gemcitabine led to an average survival increase of about 2.6 months. These findings suggest that the gemcitabine-capecitabine combination may offer significant benefits for some patients. ^{1 3 5 6 7}

Who Is on the Research Team?

Prateek Gulhati, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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've had chemotherapy for 3+ months and surgery to remove my cancer without any visible remains.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive initial chemotherapy before surgery

Varies

Surgery

Participants undergo surgical resection of pancreatic cancer

1 week

Adjuvant Chemotherapy

Participants receive gemcitabine and capecitabine every 28 days for 6 cycles

24 weeks

Day 1, Day 8, Day 15 visits per cycle

Follow-up

Participants are monitored for disease recurrence and safety every three months

30 months

Follow-up visits every three months

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Gemcitabine

Trial Overview The 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.

How Is the Trial Designed?

Group I: Group 1- Gemcitabine and Capecitabine Treatment Experimental Treatment 1 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 - Observational Active Control 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

In a study of 493 patients with resected pancreatic cancer, the modified FOLFIRINOX regimen resulted in significantly longer disease-free survival (21.6 months) and overall survival (54.4 months) compared to gemcitabine (12.8 months and 35.0 months, respectively).

While modified FOLFIRINOX showed better efficacy, it also had a higher incidence of severe adverse events (75.9% vs. 52.9% for gemcitabine), indicating a trade-off between effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. Conroy, T., Hammel, P., Hebbar, M., et al.[2023]

In a study of 58 patients with resectable metastatic pancreatic cancer treated with gemcitabine and docetaxel, the median overall survival was 52 months, with a 5-year survival rate of 49%, indicating a favorable outcome for this treatment approach.

The study found that while 52% of patients experienced significant toxicity (grade 3 or 4), the majority completed their treatment regimen, and the use of chemoradiation after gem/tax was positively associated with improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival? Kanji, ZS., Edwards, AM., Mandelson, MT., et al.[2022]

Gemcitabine is an effective antimetabolite approved for treating pancreatic cancer, showing significant clinical benefits such as pain reduction and improved performance status in patients.

The article discusses the potential of combining gemcitabine with new targeted therapies, which may enhance its effectiveness against metastatic pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine in the treatment of metastatic pancreatic cancer. Hilbig, A., Oettle, H.[2022]

In a phase II trial involving 83 patients with advanced pancreatic cancer, the combination of gemcitabine and capecitabine showed a similar overall objective response rate and survival outcomes compared to gemcitabine alone, indicating no significant advantage in efficacy from the combination treatment.

Both treatment regimens were well tolerated, with only minor increases in adverse effects, suggesting that the combination therapy has a good safety profile, although it did not significantly improve objective efficacy measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial. Scheithauer, W., Schüll, B., Ulrich-Pur, H., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 study of 100 patients with resected pancreatic cancer, the combination of uracil/tegafur (UFT) and gemcitabine (GEM) did not improve disease-free survival (DFS) compared to GEM alone, with 1-year DFS rates of 50.0% for GU and 49.0% for G.

Both treatment regimens were safe and well tolerated, with low toxicity levels, but the median overall survival (OS) was shorter in the GU group (21.2 months) compared to the G group (29.8 months), suggesting that adding UFT may not provide additional benefits.

NCBI (Pubmed)

pubmed.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. Yoshitomi, H., Togawa, A., Kimura, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 42 patients with metastatic or locally advanced pancreatic cancer, capecitabine demonstrated a clinical benefit response in 24% of patients, improving pain intensity and overall performance status.

Capecitabine was generally well tolerated, with a 9.5% objective response rate, suggesting it may be a viable treatment option for further evaluation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. Cartwright, TH., Cohn, A., Varkey, JA., et al.[2022]

In a phase II study involving 44 patients with advanced pancreatic cancer, the combination of gemcitabine, capecitabine, erlotinib, and bevacizumab showed a confirmed radiological response rate of 23%, indicating potential efficacy in this difficult-to-treat cancer.

The treatment regimen was found to be feasible with manageable side effects, including neutropenia and lethargy, and resulted in a median overall survival of 12.6 months for all patients, and 10.1 months for those with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Watkins, DJ., Starling, N., Cunningham, D., et al.[2022]

In a study of 292 patients with pancreatic ductal adenocarcinoma (PDAC), adjuvant chemotherapy with Gemcitabine plus capecitabine (GemCap) was associated with improved overall survival (OS) compared to Gemcitabine alone, with a median OS of 46.1 months for GemCap versus 36.8 months for Gem.

While GemCap showed better OS, it also had a higher incidence of side effects, including hand-foot skin reactions and neutropenia, indicating that while it may be more effective, it also comes with increased risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world outcomes of adjuvant gemcitabine versus gemcitabine plus capecitabine for resected pancreatic ductal adenocarcinoma. Kang, S., Yoo, C., Lee, SH., et al.[2022]

The combination of gemcitabine and irinotecan (IrinoGem) shows promising efficacy in treating advanced pancreatic cancer, with a 20% radiologic response rate and significant decreases in CA 19-9 levels in 32.5% of patients, based on a phase II trial of 45 patients.

The IrinoGem regimen demonstrated a higher maximum tolerated dose of irinotecan compared to previous trials, with manageable toxicity and no toxic deaths, indicating a potentially safer treatment option for patients with metastatic pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irinotecan/gemcitabine combination chemotherapy in pancreatic cancer. Rocha Lima, CM., Sherman, CA., Brescia, FJ., et al.[2022]

In a study of 74 patients with advanced, unresectable pancreatic adenocarcinoma, gemcitabine treatment resulted in a clinical benefit for 48% of those assessable, indicating its potential effectiveness even in previously treated cases.

The median overall survival for patients receiving gemcitabine was 5 months, with common side effects including myelotoxicity, nausea, and vomiting, highlighting the need for careful management of these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Compassionate use of gemcitabine in advanced pancreatic cancer: a French multicentric study]. Kurtz, JE., Trillet-Lenoir, V., Bugat, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9191365/

Efficacy and safety of gemcitabine-capecitabine combination ... Gem has acquired about a 20% increase in 1-year survival rate and a median overall survival of 5 to 7 months in metastatic pancreatic cancers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303436/

Real‐world evidence of adjuvant gemcitabine plus ... Survival with GEMCAP was superior to GEM in most subgroups of prognostic factors. Adjuvant chemotherapy was completed in 69.5% of the patients ...

3. england.nhs.uk england.nhs.uk/commissioning/wp-content/uploads/sites/12/2018/12/Evidence-Review-Gemcitabine-and-capecitabine-following-surgery-for-pancreatic-cancer.pdf

Gemcitabine plus capecitabine for adjuvant treatment in ... People who are able to have surgery to remove the tumour and be given adjuvant chemotherapy have up to a 30% chance of surviving 5 years (NICE Guideline final ...

4. cancernetwork.com cancernetwork.com/view/adding-capecitabine-gemcitabine-offers-no-overall-survival-advantage-though-could-benefit-some

Adding Capecitabine to Gemcitabine Offers No Overall ... "Patients with good performancestatus achieved a significant gain inmedian survival of 2.6 months, or 35%,when treated with GemCap. Therefore,in patients with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01161186

Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine ... The combination of nab-paclitaxel and gemcitabine in advanced pancreatic cancer demonstrated very promising results in a phase I/II study (31).

6. cancernetwork.com cancernetwork.com/view/gemcitabine-combo-may-prolong-survival-in-pancreatic-adenocarcinoma

Gemcitabine Combo May Prolong Survival in Pancreatic ... Gemcitabine plus capecitabine was found to elicit longer survival outcomes than capecitabine alone in patients with pancreatic adenocarcinoma.

7. withpower.com withpower.com/trial/phase-2-malignant-neoplasm-of-pancreas-7-2022-f59d1

Adjuvant Chemotherapy for Pancreatic Cancer The combination of gemcitabine and capecitabine (GemCap) has been shown to improve overall survival compared to gemcitabine alone, with safety evaluations ...