Pancreatic CancerPhase 2NCT00005594
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas
A Phase 2 study testing ISIS 2503 in people with Pancreatic Cancer, run by University of Alabama at Birmingham at 2 sites 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. PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas. 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?
- ISIS 2503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2000to Dec 2000
- 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 advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No other prior malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for pancreatic cancer Chemotherapy: No prior chemotherapy for pancreatic cancer except for fluorouracil and/or gemcitabine administered as a radiosensitizer No other concurrent chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed provided indicator lesions not within prior radiation port Recovered from toxicity No concurrent radiotherapy for pancreatic cancer Surgery: See Disease Characteristics Other: No concurrent anticoagulation therapy with heparin No other concurrent approved or experimental cancer therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
About this study
Official title: Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
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 ISIS 2503 in treating patients who have advanced cancer of the pancreas.
Read the detailed description
OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.
- Conditions
- Pancreatic Cancer
- Being tested
- ISIS 2503
- Keywords
- stage III 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.
ISIS 2503Drug
Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| ISIS 2503 | Experimental | All patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle. Receives: Drug: ISIS 2503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.
Measured: 24 weeks
Secondary outcomes (1)
Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startJul 2000
- Primary completionDec 2000
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 of Alabama at BirminghamThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ionis Pharmaceuticals, Inc.
- Investigators
- James A. Posey, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005594
- Sponsor's protocol ID
- CDR0000067701
- Other IDs
- UAB-9915, ISIS-2503-CS5, UAB-F990526011, NCI-G00-1730
- Status last verified
- Dec 2010
- First submitted
- 2 May 2000
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00005594
- Acronym / sponsor ID
- CDR0000067701
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ionis Pharmaceuticals, Inc.
- Study start
- Jul 2000
- Primary completion
- Dec 2000 (actual)
- First posted
- 3 May 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.
PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas.
Detailed description
OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISIS 2503 | Experimental | Drug: ISIS 2503All patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle. |
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 |
|---|---|---|
| ISIS 2503Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle. | Drug | ISIS 2503 |
Primary outcome
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.
Time frame: 24 weeks
1 secondary outcome
Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.
Time frame: 24 weeks
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 4 Jan 2011.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
James A. Posey, MD study chair
University of Alabama at Birmingham
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 ISIS 2503 in people with Pancreatic Cancer, run by University of Alabama at Birmingham 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 4 Jan 2011. 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.
What does the primary outcome measure?
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study. (time frame: 24 weeks). 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 4 Jan 2011.