BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
This study is currently recruiting participants.
Verified September 2012 by Brown University
Sponsor:
Brown University
Collaborators:
The Miriam Hospital
Rhode Island Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01744353
First received: November 26, 2012
Last updated: December 13, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
The experimental part of the study is combining these drugs together in FOLFOX-A.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Cancer |
Drug: FOLFOX-A |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BrUOG 278:FOLFOX-A For Pancreatic Cancer :A Brown University Oncology Research Group Study |
Resource links provided by NLM:
Further study details as provided by Brown University:
Primary Outcome Measures:
- Toxicity of FOLFOX-Abraxane (A) for patients with newly diagnosed, advanced pancreatic cancer. [ Time Frame: For up to 30 days post completing drug, an expected average of 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate (if patient's tumor(s)are progressing or being controlled) following treatment with FOLFOX-A for patients with newly diagnosed, advanced pancreatic cancer. [ Time Frame: pre-drug until disease progression, whichever comes first, for an expected average of 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FOLFOX- A
FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated.
|
Drug: FOLFOX-A
Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated.
Other Name: 5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Detailed Description:
More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically confirmed pancreatic ductal adenocarcinoma.
- Metastatic or locally advanced disease.
- No prior treatment for pancreatic cancer
- Radiographically measurable disease.
- No major surgery within 4 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. Laparoscopy and central venous catheter placement are not considered major surgery.
- 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
- Preexisting neuropathy > grade 1.
- 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.
- ECOG performance status 0 or 1.
- Age ≥ 18 years of age.
- 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.
Required Initial Laboratory Values:
- Neutrophils ≥ 1,500/μl
- Platelet count ≥ 100,000/μl
- Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.5 x ULN
- AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN
Exclusion Criteria:
-Patients with known brain metastases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744353
Contacts
| Contact: Kayla Rosati | 401-863-3000 | Kayla_Rosati@brown.edu |
Locations
| United States, Rhode Island | |
| Memorial Hospital | Not yet recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: Howard Safran, MD | |
| The Miriam Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
Sponsors and Collaborators
Brown University
The Miriam Hospital
Rhode Island Hospital
Memorial Hospital of Rhode Island
Investigators
| Principal Investigator: | Howard Safran, MD | Brown University |
More Information
No publications provided
| Responsible Party: | howard safran, Principal Investigator, Brown University |
| ClinicalTrials.gov Identifier: | NCT01744353 History of Changes |
| Other Study ID Numbers: | BrUOG 278 |
| Study First Received: | November 26, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Brown University:
|
newly diagnosed advanced pancreatic cancer pancreatic cancer metastatic pancreatic cancer pancreas |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013