Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Emory University
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Recurrence-free Survival as Measured by CT Scan
Study Overview
Brief Summary
The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.
The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.
Detailed Description
The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (≥ 18 years) at the time of signing informed consent form
- •Understand and voluntarily sign informed consent form
- •Able to adhere to study visit schedule and other protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •Absolute neutrophil count ≥ 1500 / mm³
- •Platelet count ≥ 100,000 / mm³
- •Resectable pancreatic adenocarcinoma
- •Pathologic diagnosis of pancreatic adenocarcinoma
Exclusion Criteria
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
- •A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
- •Presence of active infection
- •Untreated second malignancy
- •Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)
Arms & Interventions
Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Intervention: Gemcitabine (Drug)
Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Intervention: Cisplatin (Drug)
Outcomes
Primary Outcomes
Recurrence-free Survival as Measured by CT Scan
Time Frame: Every 3 months and then every 6 months for 2 more years after resection
Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.
Secondary Outcomes
- Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression(At the time of resection)
Investigators
Shishir Kumar Maithel
MD
Emory University