Chemotherapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
+258 other locations
Overseen byHeloisa P Soares
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: SWOG Cancer Research Network
Must not be taking: Warfarin
Disqualifiers: Metastatic disease, CNS metastases, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take warfarin while on the trial. Other anticoagulants are allowed, and you should discuss your specific medications with the study team.
What data supports the effectiveness of the drug combination of capecitabine and temozolomide for pancreatic cancer?
Research shows that capecitabine has been effective in treating advanced gastric and colorectal cancers, and temozolomide has shown activity in treating other types of tumors like melanoma and glioma. However, in a study specifically for pancreatic cancer, temozolomide alone was not effective, but the combination of capecitabine and temozolomide showed promise in treating pancreatic endocrine carcinomas.
12345Is temozolomide generally safe for humans?
Temozolomide is generally well tolerated and safe, with common side effects like fatigue, nausea, and mild blood-related issues. However, it can sometimes cause serious blood problems, such as myelodysplastic syndrome (a bone marrow disorder) and aplastic anemia (a condition where the body stops producing enough new blood cells).
678910How does the drug temozolomide differ from other treatments for pancreatic cancer?
Temozolomide is unique because it is an oral chemotherapy drug that is rapidly absorbed and has been used in other cancers like melanoma and glioma. However, it has shown limited effectiveness in treating pancreatic cancer, with most patients experiencing disease progression within two months.
23111213Eligibility Criteria
This trial is for adults who've had surgery for high-risk, well-differentiated pancreatic neuroendocrine tumors. They must be able to swallow pills, have no other active cancers (with some exceptions), and not have received certain treatments post-surgery. A complete medical history and physical exam are required, along with specific blood count and chemistry levels.Inclusion Criteria
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
I have had bleeding in my stomach or intestines.
Participants must have specific levels of blood cells and chemicals in their blood.
+16 more
Exclusion Criteria
Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
I do not have cancer spread to my brain or its coverings.
I have no allergies to medications similar to temozolomide or capecitabine.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive capecitabine and temozolomide orally for up to 4 cycles, each cycle lasting 28 days
16 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Every 6 months for 3 years, then annually
Participant Groups
The trial tests the effectiveness of two chemotherapy drugs, capecitabine and temozolomide, given after surgery to prevent cancer from returning in patients with high-risk pancreatic neuroendocrine tumors. The study will observe how these drugs stop tumor cells from growing or spreading.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (capecitabine, temozolomide)Experimental Treatment2 Interventions
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (surveillance)Active Control1 Intervention
Patients undergo surveillance with no active treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Alegent Health Mercy HospitalCouncil Bluffs, IA
Essentia Health Hibbing ClinicHibbing, MN
The Carle Foundation HospitalUrbana, IL
Essentia Health-Hayward ClinicHayward, WI
More Trial Locations
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Who Is Running the Clinical Trial?
SWOG Cancer Research NetworkLead Sponsor
Southwest Oncology GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. [2022]To determine the safety and efficacy of capecitabine (Xeloda; Roche Laboratories, Nutley, NJ) in patients with metastatic or unresectable, locally advanced pancreatic cancer.
First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. [2022]Temozolomide is an active agent in metastatic pancreatic endocrine carcinomas. In vitro data indicate that the combination of capecitabine and temozolomide is synergistic for induction of apoptosis in neuroendocrine tumor cell lines. The authors retrospectively evaluated the efficacy of capecitabine and temozolomide in 30 patients with metastatic pancreatic endocrine carcinomas to assess response rate, progression free survival (PFS), and overall survival (OS).
A phase II study of temozolomide in advanced untreated pancreatic cancer. [2022]Temozolomide (SCH 52365) is an imidazotetrazine derivative which exhibits broad spectrum activity against murine tumors and is structurally related to dacarbazine (DTIC). Temozolomide cytotoxicity is schedule dependent in vivo with a daily x 5 schedule showing the highest activity. Oral temozolomide is rapidly and completely absorbed with minimal interpatient and intrapatient variability in pharmacokinetics. Clinical studies have demonstrated activity against melanoma and glioma. The present study examined the activity of oral temozolomide against patients with pancreatic cancer. Patients with advanced pancreatic adenocarcinoma previously untreated with chemotherapy received temozolomide 200 mg/m2/day once daily orally for 5 days with cycles repeated every 28 days. There were 16 patients entered on study with 15 evaluable for response and toxicity. There were no responses seen in 15 evaluable patients with 14 manifesting progressive disease within 2 months of starting therapy. Toxicity was primarily hematological with 3 patients experiencing > or = grade 3 neutropenia and thrombocytopenia respectively. Other toxicities were relatively modest. In conclusion, temozolomide in the once daily x 5 schedule is inactive against adenocarcinoma of the pancreas.
[Effect of second-line treatment with capecitabine and thalidomide in patients with advanced pancreatic cancer]. [2018]This study investigates the efficacy and tolerability of capecitabine plus thalidomide in patients with advanced pancreatic cancer who previously underwent gemcitabine-based therapy.
A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. [2022]Capecitabine (Xeloda) is a novel, oral, selectively tumor-activated fluoropyrimidine with proven activity in the treatment of advanced colorectal cancer. This trial was conducted to evaluate the efficacy, safety and feasibility of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer, with a view to replacing 5-fluorouracil (5-FU) in such patients.
Hematologic adverse events associated with temozolomide. [2018]Temozolomide (TMZ) is a widely used oral alkylating agent that has been associated with the development of severe hematologic adverse events (HAEs). Limited clinical information about HAEs is available.
Phase I study of capecitabine in combination with temozolomide in the treatment of patients with brain metastases from breast carcinoma. [2018]A single-institution Phase I clinical trial was conducted to determine the maximum tolerated dose (MTD) and define the safety profile of temozolomide and capecitabine when used in combination to treat brain metastases from breast cancer.
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]Label="BACKGROUND">Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal® capsules administered to brain tumor patients.
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]Temozolomide (TMZ) is an oral alkylating agent principally indicated for neurological malignancies including glioblastoma (GBM) and astrocytoma. Most common side effects are mild to moderate, and include fatigue, nausea, vomiting, thrombocytopenia and neutropenia. Severe or prolonged myelosuppression, causing delayed treatment or discontinuation, is uncommon. Major haematological adverse effects such as myelodysplastic syndrome or aplastic anaemia (AA) have rarely been reported.
Temozolomide-related hematologic toxicity. [2018]Temozolomide (TMZ) is an oral alkylating agent used for the treatment of recurrent or newly diagnosed malignant gliomas with significant survival benefit. TMZ is generally well tolerated and safe. The most common side effects are mild to moderate, and are represented by fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. However severe hematologic adverse events (HAEs), including myelodysplastic syndrome and aplastic anemia, have also been reported. In this review we present an overview of the available literature of HAEs after exposure to TMZ.
Influence of cell cycle checkpoints and p53 function on the toxicity of temozolomide in human pancreatic cancer cells. [2021]Though an increased efficacy of carmustine and temozolomide (TMZ) has been demonstrated by inactivation of O(6)-methylguanine-DNA methyltransferase (MGMT) with O(6)-benzyl-guanine (BG) in human pancreatic tumors refractive to alkylating agents, the regulatory mechanisms have not been explored.
Biochemical changes associated with a multidrug-resistant phenotype of a human glioma cell line with temozolomide-acquired resistance. [2022]Temozolomide (TMZ) is a newly approved alkylating agent for the treatment of malignant gliomas. To investigate resistance mechanisms in a multidrug therapeutic approach, a TMZ-resistant human glioma cell line, SF188/TR, was established by stepwise exposure of human SF188 parental cells to TMZ for approximately 6 months. SF188/TR showed 6-fold resistance to TMZ and cross-resistance to a broad spectrum of other anticancer agents that included 3-5-fold resistance to melphalan (MEL), gemcitabine (GEM), paclitaxel (PAC), methotrexate (MTX), and doxorubicin (DOX), and 1.6-2-fold resistance to cisplatin (CDDP) and topotecan (TPT). Alkylguanine alkyltransferase (AGT) activity was increased significantly in the resistant cell line compared with the parental cell line (P
Future directions in the treatment of pancreatic cancer. [2022]Fewer than 20% of patients with pancreatic cancer present with disease macroscopically confined to the pancreas, and approximately 40% already have locally advanced disease. Based on data from the Gastrointestinal Tumor Study Group, adjuvant therapy with radiation and 5-fluorouracil has become standard practice in the United States; however, in other countries, adjuvant treatment has not been as widely accepted. Other issues include the potential of neoadjuvant therapy and optimal systemic management. The issue of second-line therapy has also been raised in the treatment of pancreatic carcinoma, after the establishment of gemcitabine as a first-line standard treatment approach, in which it achieves a significant clinical benefit response. Other combination partners with gemcitabine under investigation include the antimetabolite 5-fluorouracil, the topoisomerase-I inhibitor irinotecan, the taxane docetaxel, the platinum oxaliplatin, the multitargeted antifolate pemetrexed, the farnesyl transferase inhibitor R-115777, the anti-HER2/neu antibody trastuzumab, and the epidermal growth factor inhibitor cetuximab. Combined-modality approaches with gemcitabine and radiation are also under active investigation.