Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052689

Purpose

RATIONALE: 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.

PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer .

Condition	Intervention	Phase
Pancreatic Cancer	Drug: bortezomib Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Trial Of PS-341 And Gemcitabine In Patients With Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Bortezomib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

December 2002

Detailed Description:

OBJECTIVES:

Compare the objective response rate in previously untreated patients with metastatic pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine.
Compare the toxicity of these regimens in these patients.
Compare the progression-free, 6-month, and overall survival of patients treated with these regimens.
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 1 of 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.

PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study within 20-24 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 3 months

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9.0 g/dL

Hepatic

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* NOTE: *PT and PTT greater than ULN allowed provided patient is on warfarin anticoagulation and INR is no greater than 3

Renal

Creatinine no greater than 1.5 times ULN

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

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

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
More than 4 weeks since prior radiotherapy
No prior radiotherapy to 25% or more of the bone marrow
No concurrent radiotherapy

Surgery

Not specified

Other

No prior bortezomib

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052689

Show 32 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven R. Alberts, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Alberts S, Gill S, Foster N, et al.: PS-341 and gemcitabine in patients with metastatic pancreatic adenocarcinoma (ACA): final results of a North Central Cancer Treatment Group (NCCTG) randomized phase II study. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-129, 2005.

Alberts SR, Foster NR, Morton RF, Kugler J, Schaefer P, Wiesenfeld M, Fitch TR, Steen P, Kim GP, Gill S. PS-341 and gemcitabine in patients with metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group (NCCTG) randomized phase II study. Ann Oncol. 2005 Oct;16(10):1654-61. Epub 2005 Aug 5.

Study ID Numbers:	CDR0000258670, NCCTG-N014C
Study First Received:	January 24, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00052689 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

duct cell adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type

Bortezomib
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009