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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer  Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer,stage 1 pancreatic cancer
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is considered unresectable - Measurable or evaluable disease - No metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin less than 3.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min Other: - No serious concurrent systemic disorder - No active infection or uncontrolled infection - Not pregnant - Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified Other: - At least 1 month since any prior investigational agent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Additional Information:
Study ID Numbers: CDR0000066296; NYU-9703,NCI-G98-1423
Study Start Date:
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003332
Other Stage 1 Pancreatic Cancer Studies:
1. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
2. Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
3. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
4. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
5. Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
Related Studies:
Other stage 1 pancreatic cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
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