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RECRUITING

NCT05040360

PHASE2

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2022-05-05

Completion Date

2027-03-31

Last Updated

2025-12-15

Healthy Volunteers

Conditions

Metastatic Malignant Neoplasm in the Liver Pancreatic Neuroendocrine Tumor Stage I Pancreatic Neuroendocrine Tumor AJCC v8 Stage II Pancreatic Neuroendocrine Tumor AJCC v8 Stage III Pancreatic Neuroendocrine Tumor AJCC v8

Interventions

DRUG

Capecitabine

Given PO

DRUG

Temozolomide

Given PO

Inclusion Criteria: * Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam * Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report * Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria * Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points: * 1 point; symptomatic tumor defined as one of the following: * Gastrointestinal bleed * Jaundice * Gastrointestinal obstruction * Pain from primary tumor prior to surgical resection * Pancreatitis * 2 points; primary pancreas tumor size \> 2 cm * 1 point; Ki-67 3% to 20% * 1 point; lymph node positivity = 1 * 6 points; Ki-67 21% to 55% * Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection * Participants must have recovered from effects of surgery as determined by the treating investigator * Participants must be \>= 18 years old * Participants must have Zubrod performance status of 0-2 * Participants must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration) * Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration) * Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration) * Participants must be able to swallow pills * Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol * No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years * 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 Exclusion Criteria: * Participants must not have unresected or unablated metastatic disease * Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis * Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted * Participants must not have received somatostatin analogs after surgery * Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed * Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine * Participants must not have known absorption issues that would limit the ability to absorb study agents * Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration * Participants must not have active or uncontrolled infection * Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator * Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

Locations (448)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Keck Medicine of USC Buena Park

Buena Park, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Keck Medicine of USC Huntington Beach

Huntington Beach, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Mercy Cancer Center

Merced, California, United States

Providence Queen of The Valley

Napa, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Bay Area Tumor Institute

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

BASS Medical Group - Lennon

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Cancer Center of Colorado at Sloan's Lake