New York, New York 10016

  • Pancreatic Cancer

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000066296


NCT ID:

NCT00003332


Secondary ID:

P30CA016087


Study Acronym:


Brief Title:

Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Howard S. Hochster, MD
Study Chair
New York University School of Medicine

Study Dates

Start Date:July 1997
Primary Completion Date:October 2004
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 25, 2011
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:cisplatin
Intervention Type:Drug
Name:gemcitabine hydrochloride
Intervention Type:Procedure
Name:surgical procedure
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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