Pancreatic CancerPhase 2NCT00059982
Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
A Phase 2 study testing perifosine in people with Pancreatic Cancer, run by Eastern Cooperative Oncology Group at 10 sites in United States.
Trial summary
RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer. 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?
- perifosine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Jul 2003to Aug 2005
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Locally advanced, unresectable, or metastatic disease
- Measurable disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- AST no greater than 2 times upper limit of normal (ULN)
- Bilirubin no greater than 2 times ULN
Renal
- Creatinine no greater than 1.4 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for pancreatic cancer
- More than 6 months since prior chemotherapy for other diseases
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
Surgery
- At least 4 weeks since prior surgery and recovered
Other
- No other concurrent investigational agents for pancreatic cancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Tufts - New England Medical Center
Boston, Massachusetts, 02111
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Scott and White Hospital
Temple, Texas, 76508
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma
RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
- Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 35-84 patients will be accrued for this study within 21 months.
- Conditions
- Pancreatic Cancer
- Being tested
- perifosine
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startJul 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert de W. Marsh, MD, Study chair, University of FloridaCaio Max S. Rocha Lima, MD, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059982
- Sponsor's protocol ID
- CDR0000298994
- Other IDs
- ECOG-E1202
- Status last verified
- Aug 2004
- First submitted
- 6 May 2003
- Last updated
- 24 Jun 2013
- Results posted
- No
Publications
Marsh Rde W, Rocha Lima CM, Levy DE, Mitchell EP, Rowland KM Jr, Benson AB 3rd. A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2007 Feb;30(1):26-31. doi: 10.1097/01.coc.0000251235.46149.43.
PubMed 17278891
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00059982
- Acronym / sponsor ID
- CDR0000298994
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 7 May 2003 (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.
RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
- Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
- Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 35-84 patients will be accrued for this study within 21 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| perifosine | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2013.
- Results publication: PubMed 17278891Marsh Rde W, Rocha Lima CM, Levy DE, Mitchell EP, Rowland KM Jr, Benson AB 3rd. A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2007 Feb;30(1):26-31. doi: 10.1097/01.coc.0000251235.46149.43.
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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.
Robert de W. Marsh, MD study chair
University of Florida
Caio Max S. Rocha Lima, MD
H. Lee Moffitt Cancer Center and Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perifosine in people with Pancreatic Cancer, run by Eastern Cooperative Oncology Group at 10 sites 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?
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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059982, which also lists 1 linked publication.
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 24 Jun 2013.