Clinical trial · Interventional
Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas
NCT00766636CI-TRIAL-00022291terminatedPhase 2Results postedClinicalTrials.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)
Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. Secondary Objectives: * To assess disease free survival * To assess overall survival * To assess patterns of local and distant failure
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Erlotinib Without Radiation
- description
- Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Surgical removal of the pancreas and duodenum.
- interventionNames
- Drug: Gemcitabine
- Drug: Erlotinib
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Gemcitabine + Erlotinib With Radiation
- description
- Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
- interventionNames
- Drug: Gemcitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible. 2. Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment. 3. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to treatment 4. There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible. 5. Adequate renal, and bone marrow function: • Leukocytes \>= 3,000/uL • Absolute neutrophil count \>= 1,500/uL • Platelets \>= 100,000/Ul • Serum creatinine \<= 2.0 mg/dL 6. Hepatic function (endoscopic or percutaneous drainage as needed) • Total bilirubin \< = 2 X institutional upper limits of normal (ULN) • AST (SGOT)/ALT (SGPT) \<= 5 X institutional ULN 7. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy. 8. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent. 9. Patients must sign a study-specific consent form, which is attached to this protocol. Exclusion Criteria: 1. Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible. 2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure 3. Known presence of central nervous system or brain metastases 4. Inability to comply with study and/or follow-up procedures 5. Patients \< 18 years of age.
References
Publications (0)
Data not yet available
No reference posted for this study.