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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

I. Compare the objective response rate in previously untreated patients with metastatic pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine.

II. Compare the toxicity of these regimens in these patients. III. Compare the progression-free, 6-month, and overall survival of patients treated with these regimens.

IV. Compare the change in overall quality of life (QOL) and in subcomponents of QOL of patients after treatment with 2 consecutive courses of these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1of 2 treatment arms.

ARM I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.

ARM II: Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.

Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life (QOL) is assessed at baseline and before courses 2 and 4. Patients who crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm II therapy.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Conditions

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Duct Cell Adenocarcinoma of the Pancreas Stage IV Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.

Group Type EXPERIMENTAL

bortezomib

Intervention Type DRUG

Given IV

Arm II

Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.

Group Type EXPERIMENTAL

bortezomib

Intervention Type DRUG

Given IV

gemcitabine hydrochloride

Intervention Type DRUG

Given IV

Interventions

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bortezomib

Given IV

Intervention Type DRUG

gemcitabine hydrochloride

Given IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* No prior gemcitabine (even as a radiosensitizing agent)
* No prior chemotherapy

* Radiosensitizing agent as adjuvant therapy or for locally advanced disease allowed
* No other concurrent chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to 25% or more of the bone marrow
* No concurrent radiotherapy
* No prior bortezomib

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Alberts

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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North Central Cancer Treatment Group

Rochester, Minnesota, United States

Site Status

Countries

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Canada United States