Clinical trial · Interventional
R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
NCT00005843CI-TRIAL-00009385completedPhase 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)
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.
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 |
|---|---|---|---|
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: tipifarnib
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTCohen 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. PMID 12663718