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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: irinotecan hydrochloride; Drug: docetaxel; Drug: cisplatin; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00012220

CDR0000068495 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-89904

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.

PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.

Full description

OBJECTIVES:

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

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.

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

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

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

PRIOR CONCURRENT THERAPY:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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259 participants in 4 patient groups

Gemcitabine

Active Comparator group

Description:

Standard treatment

Treatment:

Drug: gemcitabine hydrochloride

Gemcitabine + cisplastin

Experimental group

Description:

Addition of cisplastin to gemcitabine

Treatment:

Drug: cisplatin

Drug: gemcitabine hydrochloride

Gemcitabine + docetaxel

Experimental group

Description:

Addition of docetaxel to gemcitabine

Treatment:

Drug: docetaxel

Drug: gemcitabine hydrochloride

Gemcitabine + Irinotecan

Experimental group

Description:

Addition of irinotecan to gemcitabine

Treatment:

Drug: gemcitabine hydrochloride

Drug: irinotecan hydrochloride