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

NCT01188109 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB00034258WCI1738-09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer

Keywords

Pancreatic Neoplasms; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival as Measured by CT Scan

  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.

  Every 3 months and then every 6 months for 2 more years after resection

Secondary Outcomes (1)

• Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression

  At the time of resection

Study Arms (1)

Gemcitabine / Cisplatin

EXPERIMENTAL

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

Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days

Also known as: Gemzar

Gemcitabine / Cisplatin

Cisplatin DRUG

Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days

Also known as: Platinol

Gemcitabine / Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

This study was limited by the small sample size and failure to accrue the 45 patients estimated to appreciate potential differences in outcomes of patients with differential ERCC1 expression.

Results Point of Contact

• Title: Shishir K. Maithel, MD
• Organization: Emory University

smaithe@emory.edu

404-778-1900

Study Officials

• Shishir Maithel, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: August 25, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 28, 2016
• Results First Posted: August 9, 2016

Record last verified: 2016-08

Locations

US (2)