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

NCT ID: NCT01188109

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine / Cisplatin

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Standard of care chemotherapy and dosage

Dose - 1000 mg/m²

Schedule - Days 1 and 15; Q 28 days

Cisplatin

Intervention Type: DRUG

Dose - 50 mg/m²

Schedule - Days 1 and 15; Q 28 days

Interventions

Gemcitabine

Standard of care chemotherapy and dosage

Dose - 1000 mg/m²

Schedule - Days 1 and 15; Q 28 days

Intervention Type: DRUG

Cisplatin

Dose - 50 mg/m²

Schedule - Days 1 and 15; Q 28 days

Intervention Type: DRUG

Other Intervention Names

Gemzar; Platinol

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Shishir Kumar Maithel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shishir Maithel, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

WCI1738-09

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00034258

Identifier Type: -

Identifier Source: org_study_id