Phase 1
N=35
BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
Metastatic Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01744353 ↗Enrolled (actual)
35
Serious AEs
54.3%
Results posted
Apr 2016
Primary outcome: Primary: Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. — 1; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dose level 1 (Drug); Dose level 2/MTD (Drug); Dose level 3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer. |
1; 1; 2 | — |
| SECONDARY 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. |
3; 17; 1 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01744353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.