Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Genotype-guided Dosing Study of mFOLFIRINOX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
This study is being done to determine the dose of a chemotherapy drug (irinotecan [irinotecan hydrochloride]) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin and is known as "FOLFIRINOX". FOLFIRINOX is a current drug therapy combination (or regimen) used for people with advanced pancreatic cancer, although this combination is not Food and Drug Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a separate clinical trial to increase survival compared to another commonly used drug in pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer, esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer, and cancers with an unknown primary location. The best dose of irinotecan to use in FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho [UDP] glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] gene) of subjects for the presence of an alteration in that gene, which may affect how the body handles irinotecan. Genes help determine some of the investigators individual characteristics, such as eye color, height and skin tone. Genes may also determine why people get certain diseases and how medicines may affect them. The result of the genetic analysis will divide subjects into one of three groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose of irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of irinotecan. Group C (approximately 10% of subjects) will receive an even lower dose of irinotecan
PRIMARY OBJECTIVES:
I. To determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of two UGT1A1
genotype groups (*1*1, *1*28) using genotype-guided dosing of irinotecan as part of the
modified (m) FOLFIRINOX regimen.
SECONDARY OBJECTIVES:
I. To determine the cumulative dose intensity of irinotecan achieved in each genotype group.
II. To determine the response rates by Response Evaluation Criteria in Solid Tumors (RECIST)
(version 1.1) for each different disease (pancreatic cancer, biliary cancers, gastric cancer,
colorectal cancer, adenocarcinoma of unknown primary) treated in the study.
OUTLINE:
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV
over 1.5 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46
hours on days 1 and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT02005315 -
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT01453153 -
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01064622 -
Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00095966 -
Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT02178436 -
Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Completed |
NCT01647828 -
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
| Terminated |
NCT01555489 -
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
|
Phase 2 | |
| Completed |
NCT01232829 -
Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
|
Phase 2 | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00735917 -
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT02896907 -
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
|
Early Phase 1 | |
| Completed |
NCT02307539 -
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
|
N/A | |
| Completed |
NCT02050178 -
Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1 | |
| Completed |
NCT01488552 -
Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01222689 -
Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT00397787 -
Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine
|
Phase 2 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 |