Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Completed · Phase 2

Conditions studied: Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer

In brief

Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with gemcitabine may kill more tumor cells.

Key facts

Study ID

NCT00052689

Run by

National Cancer Institute (NCI)

People needed

88

Starts

2002-12-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic ductal or undifferentiated adenocarcinoma consistent with a pancreatic primary for which no standard curative measures exist
• No locally advanced disease only
• No islet cell, acinar cell, or cystadenocarcinomas
• Measurable disease
• At least one lesion whose longest diameter can be accurately measured as 2 cm or greater by conventional techniques OR 1 cm or greater by spiral CT scan
• A tumor lesion in a previously irradiated area allowed provided it is histologically confirmed disease with radiographic progression from a post-radiotherapy CT scan
• No CNS metastasis
• Performance status - ECOG 0-2
• At least 3 months
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9.0 g/dL
• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (stents allowed)
• AST no greater than 5 times ULN
• PT and PTT no greater than ULN*
• Creatinine no greater than 1.5 times ULN
• No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No neuropathy greater than grade 1
• No underlying disease state associated with active bleeding
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation
• More than 4 weeks since prior biologic therapy or immunotherapy
• No concurrent immunotherapy
• No concurrent colony-stimulating factors during the first course of the study

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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