- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00052689
Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- North Central Cancer Treatment Group
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
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.
|
Given IV
|
EXPERIMENTAL: Arm II
Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
|
Given IV
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)
Time Frame: Up to 6 months
|
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)
Time Frame: At 6 months
|
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.
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At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time
Time Frame: Time from randomization to death due to any cause, assessed up to 5 years
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The distribution of survival time will be estimated using the method of Kaplan-Meier.
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Time from randomization to death due to any cause, assessed up to 5 years
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Time to disease progression
Time Frame: Time from randomization to documentation of disease progression, assessed up to 5 years
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The distribution of time to progression will be estimated using the method of Kaplan-Meier.
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Time from randomization to documentation of disease progression, assessed up to 5 years
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Time to treatment failure
Time Frame: 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
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Bortezomib
Other Study ID Numbers
- NCI-2012-01799 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH Grant/Contract)
- NCCTG-N014C
- CDR0000258670
- N014C (OTHER: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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