Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-89904 NCT00012220

Objectives

1. Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
2. Compare the time to disease progression in patients treated with these regimens.
3. Compare the CA 19-9 biomarker response in patients treated with these regimens.
4. Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.
5. Compare the toxicity of these regimens in these patients.
6. Compare the response in patients with measurable disease treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the pancreas
• Metastatic disease by CT scan

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy except fluorouracil (5-FU)
• At least 2 weeks since prior 5-FU
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic

Radiotherapy:

• At least 2 weeks since prior radiotherapy
• No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
• Alkaline phosphatase any value if SGOT less than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study
• No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

Expected Enrollment

A total of 240 patients (60 per arm) will be accrued for this study within 30 months.

Outline

This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
• Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
• Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

Kulke MH, Tempero MA, Niedzwiecki D, et al.: Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904. J Clin Oncol 27 (33): 5506-12, 2009.[PUBMED Abstract]

Kulke MH, Niedzwiecki D, Tempero MA, et al.: A randomized phase II study of gemcitabine/cisplatin, gemcitabine fixed dose rate infusion, gemcitabine/docetaxel, or gemcitabine/irinotecan in patients with metastatic pancreatic cancer (CALGB 89904). [Abstract] J Clin Oncol 22 (Suppl 14): A-4011, 316s, 2004.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Matthew Kulke, MD, Protocol chair		Ph: 617-632-5136; 866-790-4500

Registry Information
Official Title		A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer
Trial Start Date		2001-01-15
Trial Completion Date		2008-07-01
Registered in ClinicalTrials.gov		NCT00012220
Date Submitted to PDQ		2001-01-24
Information Last Verified		2003-12-10
NCI Grant/Contract Number		CA31946

Back to Top