Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Duct Cell Adenocarcinoma of the Pancreas Stage IV Pancreatic Cancer |
Drug: bortezomib Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma |
- Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]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.
- Proportion of patients alive at 6 months (Arm II) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]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.
- Survival time [ Time Frame: Time from randomization to death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Time from randomization to documentation of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 88 |
| Study Start Date: | June 2002 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
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
Other Names:
Drug: gemcitabine hydrochloride
Given IV
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Minnesota | |
| North Central Cancer Treatment Group | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Steven Alberts | North Central Cancer Treatment Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052689 History of Changes |
| Other Study ID Numbers: | NCI-2012-01799, N014C, U10CA025224, CDR0000258670 |
| Study First Received: | January 24, 2003 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Bortezomib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013