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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003332
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine

Brief Summary:

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

Detailed Description:


  • 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
Primary Purpose: Treatment
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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is considered unresectable
  • Measurable or evaluable disease
  • No metastatic disease



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks


  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin less than 3.0 mg/dL


  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min


  • No serious concurrent systemic disorder
  • No active infection or uncontrolled infection
  • Not pregnant
  • Effective contraception required of all fertile patients


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • Not specified


  • At least 1 month since any prior investigational agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003332

United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine Identifier: NCT00003332     History of Changes
Other Study ID Numbers: CDR0000066296
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by New York University School of Medicine:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs