Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00003332|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with radiation therapy and/or surgery may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, consisting of gemcitabine and cisplatin, followed by chemotherapy and radiation therapy and/or surgery in treating patients who have pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: surgical procedure Radiation: radiation therapy||Phase 1 Phase 2|
- Determine the response rate of patients with locally advanced pancreatic cancer after induction therapy with gemcitabine and cisplatin.
- Determine the maximum tolerated dose of gemcitabine and cisplatin chemotherapy combined with radiation therapy in these patients.
- Determine the overall response rates in these patients after this combined modality regimen following induction chemotherapy.
- Determine the resectability rate for locally advanced pancreatic lesions treated with this regimen.
- Determine the time to failure for the entire treatment program.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Following gemcitabine, patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Course is repeated every 4 weeks. After 2 courses of induction chemotherapy, disease is restaged.
Patients may then receive radiotherapy in addition to chemotherapy. Radiotherapy is given daily for 5 weeks and 3 days. During radiotherapy, cohorts of 3 patients are treated with escalating doses of gemcitabine and cisplatin administered as described above in induction chemotherapy. The maximum tolerated dose (MTD) is defined as the lowest dose at which no more than 2 of 6 or 2 of 3 patients experience dose limiting toxicity. When the MTD has been determined, additional patients accrued into the study receive the dose level immediately below the MTD.
If after 2 courses of induction chemotherapy with gemcitabine and cisplatin the tumor is radiographically considered resectable by operating surgeon, the patient undergoes surgical exploration or laparoscopy for staging and verification of resectability. If the tumor is found to be resectable without evidence of distant disease, the patient undergoes complete surgical resection and radiation plus adjuvant gemcitabine and cisplatin.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 15-36 patients will be accrued for the Phase I portion of this study and there will be 14-25 patients accrued into the Phase II portion of this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||Phase I/II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Combined Chemo-radiation and/or Surgical Resection for Locally Advanced Pancreatic Cancer|
|Study Start Date :||July 1997|
|Actual Primary Completion Date :||October 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003332
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|