Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Genotype-Guided Dosing Study of FOLFIRABRAX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
Verified date | May 2023 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, 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. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that FOLFIRABRAX is a reasonable therapeutic option - Patients with a history of obstructive jaundice due to the primary tumor must have a metal biliary stent in place - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 - Life expectancy > 3 months - Absolute neutrophil count (ANC) >= 1500/ul - Hemoglobin > 9 g/dL - Platelets > 100,000/ul - Total bilirubin =< 1.25 times upper limit of normal - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal - Alkaline phosphatase =< 2.5 times the upper limit of normal, unless bone metastasis is present in the absence of liver metastasis - Creatinine =< 1.5 mg/dL - Measurable or non-measurable disease will be allowed, but only those with measurable disease will be evaluable for the response rate endpoint - Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment - Negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential - Signed informed consent Exclusion Criteria: - Prior chemotherapy or radiation therapy for any cancer - Inflammatory bowel disease (Crohn's disease, ulcerative colitis) - Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v.] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement - Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0 - Documented brain metastases - Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment - Active uncontrolled bleeding - Pregnancy or breastfeeding - Major surgery within 4 weeks - Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30% - Patients taking substrates, inhibitors and inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible - Patients with any polymorphism in UGT1A1 other than *1 or *28 (e.g., *6) - History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis or connective tissue disorders - Subjects known to be human immunodeficiency virus (HIV)-positive, including those on combination antiretroviral therapy, are ineligible |
Country | Name | City | State |
---|---|---|---|
United States | The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Fort Wayne Medical Oncology/Hematology | Fort Wayne | Indiana |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Indiana University Medical Center | Indianapolis | Indiana |
United States | Virginia Mason | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DLT rate in course 1 for each of the three genotype groups, graded according to NCI CTCAE v 4.0 | 4 weeks | ||
Secondary | Incidence of adverse events graded according to NCI CTCAE v 4.0 | Adverse events will be summarized by type, grade, and attribution. | Up to 6 months | |
Secondary | Response rates (by RECIST 1.1) for patients with each different type of gastrointestinal malignancy | These results will be compared descriptively to appropriate historical controls. Exact 90% confidence intervals will be generated for the response rates. | Up to 6 months | |
Secondary | Cumulative doses of the drugs will be calculated as the sum of all doses received on protocol therapy for each patient | The means and standard deviations for patients in each genotype group will be reported. | Up to 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Completed |
NCT01959672 -
Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT03673423 -
Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
|
||
Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Not yet recruiting |
NCT06026943 -
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
|
N/A | |
Completed |
NCT03054987 -
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
|
N/A | |
Terminated |
NCT02345460 -
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
|
Phase 2 | |
Recruiting |
NCT02072616 -
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
|
Phase 3 | |
Completed |
NCT02174887 -
Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT03703063 -
Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
|
Phase 1 | |
Terminated |
NCT04077372 -
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
|
N/A | |
Recruiting |
NCT03073785 -
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT03665441 -
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
|
Phase 3 | |
Recruiting |
NCT04627246 -
Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06217666 -
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
|
Phase 1 | |
Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT04119362 -
PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
|
||
Completed |
NCT03105921 -
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
|
N/A |