Pancreatic CancerPhase 2NCT00005843
R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
A Phase 2 study testing tipifarnib in people with Pancreatic Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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?
- tipifarnib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2000to Sep 2004
- 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
- Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines)
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-2
- WBC at least 4,000/mm3 OR granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2 times normal
- Creatinine no greater than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after the study
- No concurrent illness or active infection which would preclude study
- No prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer
- No history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole)
PRIOR CONCURRENT THERAPY:
- No prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietin
- Primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease
- Primary radiotherapy allowed at least 6 months prior to detection of metastatic disease
- No concurrent use of proton pump inhibitors (e.g., omeprazole)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic cancer.
II. Determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen.
III. Assess the pharmacokinetics of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
- Conditions
- Pancreatic Cancer
- Being tested
- tipifarnib
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas, 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.
tipifarnibDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: tipifarnib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2004 (estimated)
- Study startMay 2000
- Primary completionSep 2004
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.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neal J. Meropol, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005843
- Sponsor's protocol ID
- NCI-2012-02335
- Other IDs
- FCCC-00005, NCI-45, CDR0000067859
- Status last verified
- Apr 2007
- First submitted
- 2 Jun 2000
- Last updated
- 11 Feb 2013
- Results posted
- No
Publications
Cohen SJ, Ho L, Ranganathan S, Abbruzzese JL, Alpaugh RK, Beard M, Lewis NL, McLaughlin S, Rogatko A, Perez-Ruixo JJ, Thistle AM, Verhaeghe T, Wang H, Weiner LM, Wright JJ, Hudes GR, Meropol NJ. Phase II and pharmacodynamic study of the farnesyltransferase inhibitor R115777 as initial therapy in patients with metastatic pancreatic adenocarcinoma. J Clin Oncol. 2003 Apr 1;21(7):1301-6. doi: 10.1200/JCO.2003.08.040.
PubMed 12663718
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00005843
- Acronym / sponsor ID
- NCI-2012-02335
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2000
- Primary completion
- Sep 2004 (actual)
- First posted
- 5 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.
Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic cancer.
II. Determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen.
III. Assess the pharmacokinetics of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: tipifarnibPatients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. |
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 |
|---|---|---|
| tipifarnib | Drug | Arm I |
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 11 Feb 2013.
- Results publication: PubMed 12663718Cohen SJ, Ho L, Ranganathan S, Abbruzzese JL, Alpaugh RK, Beard M, Lewis NL, McLaughlin S, Rogatko A, Perez-Ruixo JJ, Thistle AM, Verhaeghe T, Wang H, Weiner LM, Wright JJ, Hudes GR, Meropol NJ. Phase II and pharmacodynamic study of the farnesyltransferase inhibitor R115777 as initial therapy in patients with metastatic pancreatic adenocarcinoma. J Clin Oncol. 2003 Apr 1;21(7):1301-6. doi: 10.1200/JCO.2003.08.040.
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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.
Neal J. Meropol, MD study chair
Fox Chase Cancer Center
2 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 tipifarnib in people with Pancreatic Cancer, run by National Cancer Institute (NCI) at 2 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 NCT00005843, 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 11 Feb 2013.