Pancreatic CancerPhase 2NCT00053924
Perifosine in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 study testing perifosine in people with Pancreatic Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced 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
- 3 sitesCanada
- Study dates
- May 2003to May 2006
- 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 or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy
- Metastatic OR locally advanced
- No known brain metastases
- No ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN (5 times ULN with liver metastases)
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Gastrointestinal
- No gastrointestinal (GI) tract disease resulting in the inability to take oral medication or a requirement for IV alimentation
- No uncontrolled inflammatory bowel disease
- No active peptic ulcer disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine
- No other active malignant disease that could interfere with interpretation of study results
- No ongoing active infection
- No other uncontrolled concurrent illness
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 prior chemotherapy regimen for metastatic or locally advanced disease
- Prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered
Surgery
- No prior GI surgery affecting absorption
Other
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.
- Determine the safety and tolerability of this drug in these patients.
- Determine median survival time and the 1-year survival rate of patients treated with this drug.
- Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 15 months.
- Conditions
- Pancreatic Cancer
- Being tested
- perifosine
- Keywords
- recurrent pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas, 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 posted6 Feb 2003 (estimated)
- Study startMay 2003
- Primary completionMay 2006
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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Malcolm J. Moore, MD, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053924
- Sponsor's protocol ID
- PMH-PHL-015
- Other IDs
- CDR0000269586, NCI-5983
- Status last verified
- Jul 2015
- First submitted
- 5 Feb 2003
- Last updated
- 23 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00053924
- Acronym / sponsor ID
- PMH-PHL-015
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- Primary completion
- May 2006 (actual)
- First posted
- 6 Feb 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.
- Determine the safety and tolerability of this drug in these patients.
- Determine median survival time and the 1-year survival rate of patients treated with this drug.
- Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 15 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 23 Jul 2015.
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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.
Malcolm J. Moore, MD study chair
Princess Margaret Hospital, Canada
3 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 University Health Network, Toronto at 3 sites in Canada.
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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
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 23 Jul 2015.