BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02080221
• Collaborator: Lifespan (Other), SouthCoast Medical Group (Other), Memorial hospital (Other)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 91.5
• Patients Per Site: 25
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®. Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with the other 3 drugs is being investigated. Your doctors are studying the activity and side effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Cancer	Drug: FOLFOXA	Phase 2

Detailed Description

See summary above

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BrUOG 292: FOLFOX-A For Metastatic Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jan 9, 2020
• Actual Study Completion Date: Mar 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FOLFOXA 1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)	Drug: FOLFOXA; Other Names: 1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)

Outcome Measures

Primary Outcome Measures

1. Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone. [Every 3 months for up to 5 years]

Secondary Outcome Measures

1. Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen [Every 3 months for up to 5 years.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pathologically or cytological confirmed pancreatic ductal adenocarcinoma. Patients with pathology or cytology showing carcinoma of pancreas or adenosquamous of the pancreas are also eligible.

2. Metastatic advanced disease.

3. No prior chemotherapy for pancreatic cancer

4. No major surgery within 3 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. For questions on if a surgery is deemed "major," definition by surgeon can be used for clarification. Laparoscopy and central venous catheter placement are not considered major surgery.

5. No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.

6. ECOG performance status 0 or 1.

7. Age ≥ 18

8. Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause or lack of menses >12 months) do not need to have a pregnancy test, please document status.

9. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. Documentation of this being discussed required.

10. Required Initial Laboratory Values:

• Neutrophils ≥ 1,500/mm3

• Platelet count ≥ 100,000/mm3

• Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min

• Total bilirubin ≤ 1.25 x ULN

• AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN (for patients with liver metastases, AST&ALT < 5xULN)

• Alkaline phosphatase < 2.5xULN, unless bone metastasis is present and in the absence of liver metastasis

Exclusion Criteria:

1. Patients with known brain metastases

2. Prior hypersensitivity to Oxaliplatin or Abraxane ® that in the investigators opinion would put the patient at risk if re-exposed

3. Preexisting neuropathy

4. Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A 5. Patients with unstable biliary stents or with plastic stents. Information on type of stent is required at registration.

5. Patients with active infection or fever (patients on antibiotics for infection or patients getting over a cold or seasonal virus are not excluded), or known historical or active infection with HIV, hepatitis B, or hepatitis C.

6. Patients with sepsis or pneumonitis. 8. Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies that in the investigator's opinion would put the patient at an increased risk.

7. Uncontrolled diabetes. If patient has diabetes, confirmation on status (controlled or uncontrolled) required at registration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southcoast centers for cancer care	Fairhaven	Massachusetts	United States	02179
2	Lifespan Hospitals (The Miriam and RI Hospital, East Greenwich, Newport)	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• Brown University
• Lifespan
• SouthCoast Medical Group
• Memorial hospital

Investigators

• Principal Investigator: Howard Safran, MD, BrUOG

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 26, 2018

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT02080221
• Other Study ID Numbers: BrUOG 292
• First Posted: Mar 6, 2014
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Brown University: metastatic pancreatic cancer; pancreatic cancer; metastatic
• Additional relevant MeSH terms: Pancreatic Neoplasms; Leucovorin; Oxaliplatin

Study Results

Participant Flow

Arm/Group Title	FOLFOXA
Arm/Group Description	1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) FOLFOXA
Period Title: Overall Study
STARTED	50
COMPLETED	48
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	FOLFOXA
Arm/Group Description	1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) FOLFOXA
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 36%
>=65 years	32 64%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	19 38%
Male	31 62%
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	2 4%
White	46 92%
More than one race	0 0%
Unknown or Not Reported	2 4%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	Survival for Patients With Metastatic Pancreatic Cancer With First-line Treatment With FOLFOX-A as Compared to Historical Controls of Gemcitabine Alone.
Time Frame	Every 3 months for up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FOLFOXA
Arm/Group Description	1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) FOLFOXA
Measure Participants	48
Progression- free survival	5
Overall survival	11

2. Secondary Outcome

Title	Response of Patients With Metastatic Pancreatic Cancer Who Receive the FOLFOX-A Regimen
Time Frame	Every 3 months for up to 5 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FOLFOXA
Arm/Group Description	1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) FOLFOXA
Measure Participants	48
Complete response	2 4%
Partial response	12 24%
Stable disease	12 24%
Progressive disease	22 44%

Adverse Events

Time Frame	Up to 28 weeks
Arm/Group Title	FOLFOXA
Arm/Group Description	1 cycle = 14 days Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days. Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.) FOLFOXA
All Cause Mortality
	FOLFOXA
	Affected / at Risk (%)	# Events
Total	2/48 (4.2%)
Serious Adverse Events
	FOLFOXA
	Affected / at Risk (%)	# Events
Total	10/48 (20.8%)
Blood and lymphatic system disorders
Hemoptysis	1/48 (2.1%)
Acidosis	1/48 (2.1%)
Anemia	1/48 (2.1%)
Gastrointestinal disorders
Diarrhea	2/48 (4.2%)
Enterocolitis	1/48 (2.1%)
Constipation	1/48 (2.1%)
Duodenal perforation	1/48 (2.1%)
Nausea	4/48 (8.3%)
Duodenal hemorrhage	1/48 (2.1%)
Small bowel obstruction	1/48 (2.1%)
Vomiting	5/48 (10.4%)
General disorders
Multi organ failure	1/48 (2.1%)
Edema limbs	1/48 (2.1%)
Fatigue	1/48 (2.1%)
Pain	4/48 (8.3%)
Infections and infestations
Infection	5/48 (10.4%)
Peritonitis	1/48 (2.1%)
Sepsis	2/48 (4.2%)
Injury, poisoning and procedural complications
Acute kidney injury	2/48 (4.2%)
Investigations
Thrombocytopenia	2/48 (4.2%)
Blood bilirubin elevated	1/48 (2.1%)
Metabolism and nutrition disorders
Hyperglycemia	2/48 (4.2%)
Anorexia	1/48 (2.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified	1/48 (2.1%)
Nervous system disorders
Lethargy	1/48 (2.1%)
Stroke	1/48 (2.1%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/48 (2.1%)
Cough	1/48 (2.1%)
Respiratory failure	1/48 (2.1%)
Dyspnea	3/48 (6.3%)
Vascular disorders
Thromboembolic event	2/48 (4.2%)
Other (Not Including Serious) Adverse Events
	FOLFOXA
	Affected / at Risk (%)	# Events
Total	48/48 (100%)
Blood and lymphatic system disorders
Anemia	30/48 (62.5%)
Gastrointestinal disorders
Diarrhea	20/48 (41.7%)
Vomiting	12/48 (25%)
Nausea	21/48 (43.8%)
Mucositis oral	6/48 (12.5%)
General disorders
Fatigue	36/48 (75%)
Investigations
Neutropenia	21/48 (43.8%)
Thrombocytopenia	36/48 (75%)
Weight loss	30/48 (62.5%)
Elevated AST/ALT	22/48 (45.8%)
Elevated alkaline phosphatase	37/48 (77.1%)
Metabolism and nutrition disorders
Anorexia	13/48 (27.1%)
Nervous system disorders
Peripheral sensory neuropathy	33/48 (68.8%)
Arthralgia	2/48 (4.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.