Bortezomib With Or Without Gemcitabine In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

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

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.

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.

Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer

DRUG: bortezomib
DRUG: gemcitabine hydrochloride

NCI-2012-01799
NCI-2012-01799 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
NCCTG-N014C
CDR0000258670
N014C (OTHER Identifier) (OTHER: North Central Cancer Treatment Group)
N014C (OTHER Identifier) (OTHER: CTEP)
U10CA025224 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-10-07
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-10-08
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DRUG: bortezomib Given IV DRUG: gemcitabine hydrochloride Given IV
EXPERIMENTAL: Arm II Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.	DRUG: bortezomib Given IV DRUG: gemcitabine hydrochloride Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

DRUG: bortezomib

Given IV

DRUG: gemcitabine hydrochloride

Given IV

EXPERIMENTAL: Arm II

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

DRUG: bortezomib

Given IV

DRUG: gemcitabine hydrochloride

Given IV

Primary Outcome Measures	Measure Description	Time Frame
Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)	An evaluable patient will be classified as a treatment 'success' if they have a confirmed tumor response (CR, PR). The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.	Up to 6 months
Proportion of patients alive at 6 months (Arm II)	An evaluable patient will be classified a treatment 'success' if they are alive at 6 months. The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.	At 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Survival time	The distribution of survival time will be estimated using the method of Kaplan-Meier.	Time from randomization to death due to any cause, assessed up to 5 years
Time to disease progression	The distribution of time to progression will be estimated using the method of Kaplan-Meier.	Time from randomization to documentation of disease progression, assessed up to 5 years
Time to treatment failure		Time from the date of randomization to the date at which the patient is removed from the treatment due to progression, toxicity, or refusal, assessed up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Steven Alberts, North Central Cancer Treatment Group

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Clinical Trial Record