Clinical trial NCT00202800: Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Official title: Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Gemcitabine/Etoposide
Ras-mutation
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
name: Eli Lilly and Company
name: Battle Creek Health System
name: Mercy Health System
name: Metropolitan Hospital, Michigan
name: Mecosta County General Hospital
name: Munson Medical Center
name: Saint Mary's Health Network
First posted: 2005-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer.

Detailed description: This is a Phase II single-armed study evaluating potential benefits of the gemcitabine and etoposide combination in the treatment of patients with locally advanced or metastatic pancreatic cancer. The study will involve approximately 30-40 adult patients with pancreatic cancer. Response rate, duration of response, overall survival, quality of life and toxicity associated with the combination therapy will be evaluated.

Primary Objective To evaluate the response rate of patients with histologically or cytologically confirmed pancreatic cancer, previously untreated with chemotherapy with the exception of 5FU given as part of an adjuvant regimen, who receive the gemcitabine-etoposide combination therapy.

Secondary Objectives 1. To evaluate the duration of response in the defined study population. 2. To evaluate the overall survival. 3. To evaluate the quality of life associated with this treatment combination.4.To describe the toxicity profile. 5.To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis, disease progression, treatment outcomes, survival, and/or treatment-associated toxicity by proteomics and microarray technologies.

Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced or metastatic adenocarcinoma of the pancreas.
* Patients may have received prior immunotherapy, radiation therapy, or surgery, but must be \> 4 weeks out from therapy and have recovered fully from its effects.
* Patients must be 18 years of age or older.
* Patients must have unidimensional measurements obtainable using RECIST criteria (see Protocol Attachment E).
* Karnofsky Performance Scale must be 50 or better (see Protocol Attachment A).
* Patient must have the following hematologic and chemical parameters:

  * ANC \> 1,000 cells/mm3
  * Hemoglobin \> 9 gm/dL
  * Platelets \> 100,000 cells/mm3
  * SGOT/SGPT \< 3 x normal, unless there is known liver involvement. Then they must be \< 5x normal.
  * Bilirubin \< 2.0 mg/dL
  * Creatinine \< 2.0 mg/dL
* Female within childbearing years must use an accepted contraceptive method.
* Patient must have a life expectancy of at least eight (8) weeks.
* A signed informed consent must be obtained prior to study entry.

Exclusion Criteria:

* Previous chemotherapy with the exception of 5FU given as part of an adjuvant regimen.
* Pregnant or nursing females.
* Concurrent radiation therapy.
* Patients with other active neoplasms are ineligible.
* Patients with serious active infections or other underlying medical conditions, which would impair their ability to receive the treatment as prescribed.

Disease Diagnostic Criteria and Staging:

* Patients must have a histologic or cytologic diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas using standard pathologic criteria.
* Staging will be according to AJCC criteria.

Primary outcomes:
measure: To evaluate the response rate
timeFrame: study completion
Secondary outcomes:
measure: To evaluate the duration of response
timeFrame: study completion
measure: To evaluate the overall survival
timeFrame: study completion
measure: To evaluate the quality of life
timeFrame: study completion
measure: To describe the toxicity profile
timeFrame: study completion
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
Study officials:
affiliation: Grand Rapids Clinical Oncology Program
name: Marianne Lange, MD
role: PRINCIPAL_INVESTIGATOR
References: