Pancreatic CancerPhase 2NCT00202800
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Etoposide in people with Pancreatic Cancer, run by Corewell Health West at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, Etoposide
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Etoposide
- Keywords
- Pancreatic Cancer, Gemcitabine/Etoposide, Ras-mutation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response rate
Measured: study completion
Secondary outcomes (4)
To evaluate the duration of response
Measured: study completion
To evaluate the overall survival
Measured: study completion
To evaluate the quality of life
Measured: study completion
To describe the toxicity profile
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionSep 2007
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Van Andel Research Institute, Eli Lilly and Company, Battle Creek Health System, Mercy Health System, Metropolitan Hospital, Michigan, Mecosta County General Hospital, Munson Medical Center, Saint Mary's Health Network
- Investigators
- Marianne Lange, MD, Principal investigator, Grand Rapids Clinical Oncology Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202800
- Sponsor's protocol ID
- VARI-002-1
- Status last verified
- May 2023
- First submitted
- 12 Sep 2005
- Last updated
- 2 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00202800
- Acronym / sponsor ID
- VARI-002-1
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Gemcitabine/Etoposide, Ras-mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Van Andel Research Institute, Eli Lilly and Company, Battle Creek Health System, Mercy Health System, Metropolitan Hospital, Michigan, Mecosta County General Hospital, Munson Medical Center, Saint Mary's Health Network
- Study start
- Mar 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine, EtoposidePancreatic 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 | Drug | – |
Primary outcome
To evaluate the response rate
Time frame: study completion
4 secondary outcomes
To evaluate the duration of response
Time frame: study completion
To evaluate the overall survival
Time frame: study completion
To evaluate the quality of life
Time frame: study completion
To describe the toxicity profile
Time frame: study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Lange, MD principal investigator
Grand Rapids Clinical Oncology Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Etoposide in people with Pancreatic Cancer, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the response rate (time frame: study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.