Trial Outcomes & Findings for Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision (NCT NCT01188109)

Last Updated: 2016-09-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2016-09-28

Participant Flow

Patients who underwent resection of a pancreatic adenocarcinoma (PDAC) were enrolled postoperatively at Winship Cancer Institute of Emory University from 2010-2013.

Twenty-five patients were initially enrolled. Three patients were thereafter excluded; two were diagnosed with secondary malignancies (primary lung adenocarcinoma and thyroid cancer), and one had a diagnosis of cholangiocarcinoma on final surgical pathology.

Participant milestones

Participant milestones
Measure	Gemcitabine / Cisplatin Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine / Cisplatin n=22 Participants Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
Age, Continuous	60.0 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Gemcitabine / Cisplatin n=22 Participants Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
Recurrence-free Survival as Measured by CT Scan	16.7 months Interval 6.9 to 26.4

SECONDARY outcome

Timeframe: At the time of resection

Population: Twenty patients had tissue available for ERCC1 analysis.

To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1-10%; 2 = 11-50%; 3 = 51-100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: \[(1+intensity score)/3\]\*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and \> 2 was high ERCC1 expression.

Outcome measures

Outcome measures
Measure	Gemcitabine / Cisplatin n=20 Participants Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression Low Tumor ERCC1 Expression	15 patients
Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression High Tumor ERCC1 Expression	5 patients

Adverse Events

Gemcitabine / Cisplatin

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine / Cisplatin n=22 participants at risk Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
Blood and lymphatic system disorders Thrombocytopenia	4.5% 1/22
Blood and lymphatic system disorders Neutropenia	4.5% 1/22
Vascular disorders Pulmonary Embolus	4.5% 1/22

Other adverse events

Other adverse events
Measure	Gemcitabine / Cisplatin n=22 participants at risk Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy. Gemcitabine: Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days Cisplatin: Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days
General disorders Fatigue	4.5% 1/22
General disorders Nausea/Vomiting	4.5% 1/22
Renal and urinary disorders Renal Insufficiency	4.5% 1/22
Blood and lymphatic system disorders Anemia	4.5% 1/22
Blood and lymphatic system disorders Neutropenia	36.4% 8/22

Additional Information

Shishir K. Maithel, MD

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place