Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT05360732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2022-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Redefining FOLFIORINOX in Older Pancreatic Cancer Patients
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Redefining The Use Of A FOLFIRINOX-Like Regimen In the Front Line In Older Patients With Metastatic Pancreatic Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi- centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years.
Detailed Description:
This is a multi-centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years. Treatment will be given in the outpatient infusion room or clinical research unit. Reported adverse events and potential risks of these agents are described below. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
The study will accrue 37 patients who will be evaluated by correlating their daily activity via use of FitBit that will be provided to the patients, blood markers and progression of the disease with the toxicity grades observed during the treatment. Patients will be treated with standard of care doses of all the chemotherapeutic drugs. The study will be analyzed for futility after treatment of 20 patients. Each cycle consists of 28 days during which patient treatment will alternate between FOLFOX and FOLFIRI on day 1 and day 14 respectively. Patients will be treated until disease progression or any of the conditions listed in Section 4.4 that applies. Patient's response to treatment will be evaluated by CT scans every 8 weeks and the tumor will be assessed using RECIST v1.1 criteria.
The study will accrue 37 patients who will be evaluated by correlating their daily activity via use of FitBit that will be provided to the patients, blood markers and progression of the disease with the toxicity grades observed during the treatment. Patients will be treated with standard of care doses of all the chemotherapeutic drugs. The study will be analyzed for futility after treatment of 20 patients. Each cycle consists of 28 days during which patient treatment will alternate between FOLFOX and FOLFIRI on day 1 and day 14 respectively. Patients will be treated until disease progression or any of the conditions listed in Section 4.4 that applies. Patient's response to treatment will be evaluated by CT scans every 8 weeks and the tumor will be assessed using RECIST v1.1 criteria.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GI-170 | OTHER | Fox Chase Cancer Center | View |