BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

NCT02022033 | Completed Phase 2 Results DMC

• 1 other identifier: 295
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a better regimen in the adjuvant setting for patients with resected pancreatic cancer. This protocol will obtain preliminary data on safety and disease-free and overall survival following administration of FOLFOX-A for patients with resected pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Adjuvant; Pancreas; Resected; Invasive adenocarcinoma; adenosquamous cancer; Intraductal papillary mucinous neoplasm

Outcome Measures

Primary Outcomes (1)

• Feasibility of Adjuvant FOLFOX-A

  Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.

  Up to 24 weeks

Secondary Outcomes (1)

• Disease-free Survival

  Through study completion, an average of 3 years.

Study Arms (1)

FOLFOXA

EXPERIMENTAL

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

Interventions

FOLFOXA DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
• Interval between definitive tumor-related surgery and registration between 21-70 days.
• Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
• Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
• Preexisting neuropathy \< grade 1 (per CTCAE).
• ECOG performance status 0 or 1.
• Age ≥ 18
• 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 of lack of menses \>12 months) do not need to have a pregnancy test, please document status.
• Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
• 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 ≤ 1.5 x ULN
• AST (SGOT) \& ALT (SGPT) ≤ 2.5 x ULN

You may not qualify if:

• 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
• Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed
• Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
• Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study
• 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. This must be documented.

Sponsors & Collaborators

• Brown University: lead

Study Sites (2)

Roxanne Wood

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Howard Safran, MD
• Organization: Brown University Oncology Research Group

BrUOG@BROWN.EDU

401-863-3000

Study Officials

• Howard Safran, MD

  BrUOG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2014
• Primary Completion: July 23, 2019
• Study Completion: March 17, 2022
• Last Updated: June 1, 2022
• Results First Posted: September 8, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)