Clinical trial · Interventional
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas
Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
NCT00005594CI-TRIAL-00004246completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ISIS 2503 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ISIS 2503
- description
- 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.
- interventionNames
- Drug: ISIS 2503
Primary outcomes (1)
- 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.
- timeFrame
- 24 weeks
Secondary outcomes (1)
- measure
- Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.