Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
- 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)
Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (radiation therapy, paclitaxel, gemcitabine)
- description
- Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: paclitaxel
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II (radiation therapy, tipifarnib)
- description
- Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.
- interventionNames
- Drug: tipifarnib
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas * Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed * No metastases in major viscera * No peritoneal seeding or ascites * Biliary or gastroduodenal obstruction must have drainage before starting study therapy * Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum) * Performance status - Zubrod 0-1 * Granulocyte count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 * ALT less than 3 times upper limit of normal * Bilirubin less than 2.0 mg/dL * Creatinine less than 3.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder * No significant infection or other medical condition that would preclude study * No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer * No other concurrent cytotoxic agents * See Disease Characteristics * No prior radiotherapy to the planned field * No other concurrent radiotherapy * See Disease Characteristics * No other concurrent investigational agents
References
Publications (0)
Data not yet available