NCT00202800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

5.5 years

First QC Date

September 12, 2005

Last Update Submit

May 31, 2023

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerGemcitabine/EtoposideRas-mutation

Outcome Measures

Primary Outcomes (1)

  • To evaluate the response rate

    study completion

Secondary Outcomes (4)

  • To evaluate the duration of response

    study completion

  • To evaluate the overall survival

    study completion

  • To evaluate the quality of life

    study completion

  • To describe the toxicity profile

    study completion

Interventions

Gemcitabine, EtoposideDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineEtoposide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Marianne Lange, MD

    Grand Rapids Clinical Oncology Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2002

Primary Completion

September 1, 2007

Study Completion

January 1, 2011

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

US(1)