Clinical trial · Interventional
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
NCT01693276CI-TRIAL-00019579terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemzar/Abraxane and Radiation Therapy
- description
- Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
- interventionNames
- Drug: Gemcitabine
- Drug: Abraxane
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Increase overall survival
- timeFrame
- 23 months
- description
- Estimated increase in median survival from 11 to 16 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven carcinoma of the pancreas that is locally advanced * ECOG performance status 0- 2 * Adequate labs * No prior abdominal radiation therapy * No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years * All disease must be encompassed within a radiotherapy portal * Not pregnant or nursing Exclusion Criteria: * Patient has metastatic disease on radiological staging * systemic therapy. * Patient has known active infection with HIV, hepatitis C or hepatitis B * Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug. * Patient is deemed to be have obvious resectable disease at presentation * Received any investigational agent within a month prior to enrollment. * Neuroendocrine tumors of the pancreas
References
Publications (0)
Data not yet available
No reference posted for this study.