FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

• Sponsor: University of Oklahoma (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01359007
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of Pancreas	Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: FOLFIRINOX Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.

Drug: Irinotecan, Oxaliplatin, Leucovorin, 5-FU; 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently

Outcome Measures

Primary Outcome Measures

1. To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy. [2 years]

Secondary Outcome Measures

1. Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy. [2 years]

2. Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria) [2 years]

3. Overall Survival [2 years]

4. Number of Participants Who Experienced Toxicity [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas

• Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry

• No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans

• Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age

• Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer

• Patients must have adequate blood counts at baseline and blood chemistry levels

• Patient has ECOG Performance Status 0 to 1

Exclusion Criteria:

• Patients with islet cell neoplasms excluded

• Patients with known brain metastases

• Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

• Known infection with HIV, hepatitis B or hepatitis C

• Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment in study

• Prior chemotherapy or radiation for pancreatic cancer

• History of allergy or hypersensitivity to the study drugs

• Patient is enrolled in any other clinical protocol or investigational trial

• Metastatic disease on radiological staging

• Prior malignancy within last 3 years

• Significant cardiac disease

• Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk

• peripheral sensory neuropathy > or equal to grade 2 at baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma

Investigators

• Principal Investigator: Shubham Pant, MD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01359007
• Other Study ID Numbers: 1977
• First Posted: May 24, 2011
• Last Update Posted: Mar 9, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by University of Oklahoma: Locally advanced unresectable adenocarcinoma of pancreas; Borderline resectable adenocarcinoma of pancreas
• Additional relevant MeSH terms: Adenocarcinoma; Leucovorin; Oxaliplatin; Irinotecan

Study Results

Participant Flow

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Period Title: Overall Study
STARTED	5
COMPLETED	3
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Overall Participants	5
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 20%
White	3 60%
More than one race	1 20%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data was not collected from any single study participant.

Arm/Group Title	5-FU, Leucovorin, Oxaliplatin, Irinotecan
Arm/Group Description	As per above
Measure Participants	0

2. Secondary Outcome

Title	Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data was not collected from any single study participant

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Measure Participants	0

3. Secondary Outcome

Title	Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data was not collected from any single study participant.

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Measure Participants	0

4. Secondary Outcome

Title	Overall Survival
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data was not collected from any single study participant.

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Measure Participants	0

5. Secondary Outcome

Title	Number of Participants Who Experienced Toxicity
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
Measure Participants	5
Count of Participants [Participants]	2 40%

Adverse Events

Time Frame	2 years
Arm/Group Title	FOLFIRINOX
Arm/Group Description	Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded. Irinotecan, Oxaliplatin, Leucovorin, 5-FU: 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
All Cause Mortality
	FOLFIRINOX
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	FOLFIRINOX
	Affected / at Risk (%)	# Events
Total	2/5 (40%)
Hepatobiliary disorders
biliary obstruction	1/5 (20%)	1
Injury, poisoning and procedural complications
Post-operative bleeding	1/5 (20%)	1
Other (Not Including Serious) Adverse Events
	FOLFIRINOX
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.