Phase 3
N=546
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Pancreatic Adenocarcinoma · Pancreatic Ductal Adenocarcinoma · Pancreatic Intraductal Papillary-Mucinous Neoplasm · Stage I Pancreatic Cancer AJCC v6 and v7 · Stage II Pancreatic Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT01013649 ↗Enrolled (actual)
546
Serious AEs
21.9%
Results posted
Oct 2024
Primary outcome: Primary: Overall Survival (Percentage of Participants Alive) [Phase II] — 29.9; 28.1 months — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Biospecimen Collection (Procedure); Capecitabine (Drug); Chemotherapy (Drug); Computed Tomography (Procedure); Erlotinib Hydrochloride (Drug); Fluorouracil (Drug); Gemcitabine Hydrochloride (Drug); Intensity-Modulated Radiation Therapy (Radiation); Magnetic Resonance Imaging (Procedure); Quality-of-Life Assessment (Other); X-Ray Imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (Percentage of Participants Alive) [Phase II] |
29.9; 28.1 | 0.62 |
| PRIMARY Overall Survival (Percentage of Participants Alive) [Phase III] |
31.1; 27.3 | 0.38 |
| SECONDARY Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II] |
12.7; 12.4 | — |
| SECONDARY Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III] |
12.4; 15.6 | — |
| SECONDARY Number of Participants by Highest Grade Adverse Event Reported (Phase II) |
6; 3; 20; 24; 100; 101 | — |
| SECONDARY Number of Participants by Highest Grade Adverse Event Reported (Phase III) |
22; 16; 50; 56; 67; 79 | — |
| SECONDARY Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group |
54.1; 58.1; 21.1; 25.1 | 0.21 |
Summary
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
- Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
- The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins-bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
- For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
- Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the College of American Pathologists (CAPS) format is strongly encouraged
- Age >= 18
- Zubrod performance status 0 or 1
- Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
- Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- Post resection serum cancer antigen (CA)19-9 = 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed
Exclusion Criteria
- Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely intraductal papillary mucinous neoplasms (IPMN) with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
- Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
- Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Previous history of invasive malignancy (except
Data sourced from ClinicalTrials.gov (NCT01013649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.