Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 10:04 AM
Study NCT ID:
NCT01473303
Status:
WITHDRAWN
Last Update Posted:
2016-06-28
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Phase IB/Randomized Phase II Study of Folfirinox Plus AMG-479 (Ganitumab) or Placebo in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CALGB 81003 closed about a week after it was activated because of withdrawal of support. No patients were registered on this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective with or without ganitumab in treating patients with pancreatic cancer.
PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and ganitumab and how well combination chemotherapy with or without ganitumab works in treating patients with previously untreated metastatic pancreatic cancer.
PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and ganitumab and how well combination chemotherapy with or without ganitumab works in treating patients with previously untreated metastatic pancreatic cancer.
Detailed Description:
OBJECTIVES:
Primary
* To assess the safety and determine the maximally tolerated dose (MTD) of modified FOLFIRINOX (mFOLFIRINOX) and ganitumab in patients with previously untreated, metastatic pancreatic adenocarcinoma. (phase I)
* To compare overall survival of patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo. (phase II)
* To assess the convergent validity of each selected PRO-CTCAE item by comparing each item at baseline between patients with ECOG performance status (PS) 0 vs 1. (phase II)
Secondary
* To compare objective response rate, duration of response, and progression-free survival of patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo.
* To compare treatment-related toxicity in patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo.
* To assess the responsiveness (sensitivity to change) of Patient-Reported Outcomes (PRO)-CTCAE by comparing change scores within groups of patients as defined by changes in ECOG PS at post-baseline administrations. (phase II)
* To compare the maximum post-baseline score for each PRO-CTCAE item per patient between arms in the randomized phase II component of the study. (exploratory).
OUTLINE: This is a dose-escalation, phase IB study followed by a randomized phase II study. Patients in the phase II study are stratified according to ECOG performance status of 0 versus 1.
* Phase IB: Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 48 hours beginning on day 2 (mFOLFIRINOX). After cohort 0, subsequent patients also receive ganitumab IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients are randomized to 1 of 2 treatment arms:
* Arm I: Patients receive mFOLFIRINOX as in Phase IB and ganitumab IV over 30-60 minutes on day 1.
* Arm II: Patients receive mFOLFIRINOX as in Phase IB and placebo IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Patients randomized in the phase II component of the study may complete 16 Patient-Reported Outcomes (PRO)-CTCAE items (measuring 8 symptoms) on paper on day 1 of all odd-numbered courses (i.e., courses 1, 3, 5, etc.).
Tumor tissue and blood samples may be collected for correlative studies.
After completion of study therapy, patients are followed every 3 months for 3 years.
Primary
* To assess the safety and determine the maximally tolerated dose (MTD) of modified FOLFIRINOX (mFOLFIRINOX) and ganitumab in patients with previously untreated, metastatic pancreatic adenocarcinoma. (phase I)
* To compare overall survival of patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo. (phase II)
* To assess the convergent validity of each selected PRO-CTCAE item by comparing each item at baseline between patients with ECOG performance status (PS) 0 vs 1. (phase II)
Secondary
* To compare objective response rate, duration of response, and progression-free survival of patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo.
* To compare treatment-related toxicity in patients with previously untreated, metastatic pancreatic adenocarcinoma who receive mFOLFIRINOX plus ganitumab versus mFOLFIRINOX plus placebo.
* To assess the responsiveness (sensitivity to change) of Patient-Reported Outcomes (PRO)-CTCAE by comparing change scores within groups of patients as defined by changes in ECOG PS at post-baseline administrations. (phase II)
* To compare the maximum post-baseline score for each PRO-CTCAE item per patient between arms in the randomized phase II component of the study. (exploratory).
OUTLINE: This is a dose-escalation, phase IB study followed by a randomized phase II study. Patients in the phase II study are stratified according to ECOG performance status of 0 versus 1.
* Phase IB: Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 48 hours beginning on day 2 (mFOLFIRINOX). After cohort 0, subsequent patients also receive ganitumab IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients are randomized to 1 of 2 treatment arms:
* Arm I: Patients receive mFOLFIRINOX as in Phase IB and ganitumab IV over 30-60 minutes on day 1.
* Arm II: Patients receive mFOLFIRINOX as in Phase IB and placebo IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Patients randomized in the phase II component of the study may complete 16 Patient-Reported Outcomes (PRO)-CTCAE items (measuring 8 symptoms) on paper on day 1 of all odd-numbered courses (i.e., courses 1, 3, 5, etc.).
Tumor tissue and blood samples may be collected for correlative studies.
After completion of study therapy, patients are followed every 3 months for 3 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: