Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

Emory University

Status and phase: Terminated; Phase 2

Conditions: Pancreatic Cancer; Pancreatic Neoplasms

Treatments: Drug: Gemcitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01188109

IRB00034258

WCI1738-09 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults (≥ 18 years) at the time of signing informed consent form
2. Understand and voluntarily sign informed consent form
3. Able to adhere to study visit schedule and other protocol requirements
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
5. Absolute neutrophil count ≥ 1500 / mm³
6. Platelet count ≥ 100,000 / mm³
7. Resectable pancreatic adenocarcinoma
8. Pathologic diagnosis of pancreatic adenocarcinoma

Exclusion criteria

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
2. A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
3. Presence of active infection
4. Untreated second malignancy
5. 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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Gemcitabine / Cisplatin

Experimental group

Description:

Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.

Treatment:

Drug: Cisplatin

Drug: Gemcitabine