Pancreatic CancerPhase 2NCT00003769
Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
A Phase 2 study testing perillyl alcohol and surgical procedure in people with Pancreatic Cancer, run by Indiana University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. 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?
- perillyl alcohol and surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Jul 2001
- 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 stage II or stage III pancreatic adenocarcinoma that is considered resectable Lesions should be amenable to surgery with curative intent Bidimensionally measurable or evaluable disease No evidence of metastatic disease No clinically detectable third space fluid collections (e.g., ascites or effusions)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.5 g/dL Hepatic: Bilirubin no greater than 4 times upper limit of normal (ULN) PTT no greater than 1.5 times control (unless on anticoagulants) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious systemic disorders incompatible with study No active infection No second primary malignancy, previously untreated with curative intent or presently active, that would preclude curative resection of the pancreas
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for pancreatic carcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for pancreatic carcinoma Surgery: See Disease Characteristics Other: At least 1 month since prior investigational agents At least 72 hours since prior anticoagulant therapy, cholesterol-lowering agents (e.g., lovastatin), high dosage vitamins, or antioxidants No concurrent anticoagulants except for the sole purpose of central line patency maintenance No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
About this study
Official title: A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage II or stage III pancreatic cancer.
Read the detailed description
OBJECTIVES: I. Assess the biologic activity of perillyl alcohol in patients with potentially resectable, stage II or stage III pancreatic adenocarcinoma. II. Characterize the acute toxicity of this drug in these patients. III. Evaluate the antitumor activity of this drug in these patients. IV. Monitor and quantitate the plasma levels of perillyl alcohol after oral administration in this patient population.
OUTLINE: Patients receive oral perillyl alcohol 4 times daily on days 1-14. Patients undergo surgical resection on day 15. There is no continuation of perillyl alcohol postoperatively. Patients are followed at a minimum of 2 and 4 months following surgery.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 12-18 months.
- Conditions
- Pancreatic Cancer
- Being tested
- perillyl alcohol, surgical procedure
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perillyl alcoholDrug
surgical procedureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2004 (estimated)
- Study startFeb 1999
- Primary completionJul 2001
- Study completionJul 2001
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 Indiana UniversityThe 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
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Patrick J. Loehrer, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003769
- Sponsor's protocol ID
- 9710-07; T98-0046
- Other IDs
- IUMC-9710-07, NCI-T98-0046
- Status last verified
- Sep 2014
- First submitted
- 1 Nov 1999
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perillyl Alcohol in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00003769
- Acronym / sponsor ID
- 9710-07; T98-0046
- Conditions
- Pancreatic Cancer
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1999
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 31 Mar 2004 (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. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage II or stage III pancreatic cancer.
Detailed description
OBJECTIVES: I. Assess the biologic activity of perillyl alcohol in patients with potentially resectable, stage II or stage III pancreatic adenocarcinoma. II. Characterize the acute toxicity of this drug in these patients. III. Evaluate the antitumor activity of this drug in these patients. IV. Monitor and quantitate the plasma levels of perillyl alcohol after oral administration in this patient population.
OUTLINE: Patients receive oral perillyl alcohol 4 times daily on days 1-14. Patients undergo surgical resection on day 15. There is no continuation of perillyl alcohol postoperatively. Patients are followed at a minimum of 2 and 4 months following surgery.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| perillyl alcohol | Drug | – |
| surgical procedure | Procedure or surgery | – |
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 10 Sep 2014.
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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.
Patrick J. Loehrer, MD study chair
Indiana University
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 perillyl alcohol and surgical procedure in people with Pancreatic Cancer, run by Indiana University 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?
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 10 Sep 2014. 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.
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 10 Sep 2014.