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

NCT ID: NCT00003332

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

surgical procedure

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Principal Investigators

Howard S. Hochster, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA016087

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYU-9703

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1423

Identifier Type: -

Identifier Source: secondary_id

CDR0000066296

Identifier Type: -

Identifier Source: org_study_id