Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT00416793
• Date of registration: 27/12/2006
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
• Scientific title: A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
• Date of first enrolment: December 2006
• Target sample size: 9
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00416793
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gauri Varadhachary
• Affiliation: MD Anderson Cancer Network

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma or
carcinoma of the pancreas that is metastatic and not amenable to resection with
curative intent

- Patients must have measurable disease defined by RECIST criteria; for the purpose of
this study, primary mass in the pancreas is not considered as measurable disease

- Patients must have received one (1), and only one, prior systemic regimen for
metastatic disease; patients who have received prior cisplatin or oxaliplatin are
eligible; a systemic regimen administered for unresectable locally advanced disease
that subsequently progressed to metastatic will be counted as 1 prior regimen;
chemotherapy administered as adjuvant therapy or as a radiation sensitizer is not
counted as a prior regimen

- Prior radiation is permitted; however, at least 3 weeks must have elapsed since the
completion of prior radiation therapy and patients must have recovered from all
associated toxicities to NCI Common Terminology Criteria for Adverse Events (CTCAE)
Version 3.0 = Grade 1 at the time of registration; measurable disease must be outside
the previous radiation field or a new lesion inside the port must be present

- At least two weeks must have elapsed since any major surgery and patients must have
recovered from all associated toxicities to = CTCAE Grade 1 at the time of
registration

- At least 4 weeks must have elapsed since previous chemotherapy except for regimens
that are administered on a daily, weekly, or every other week schedule, in which case
at least 2 weeks must have elapsed since previous chemotherapy; patients must have
recovered from all associated toxicities to CTCAE = Grade 1 at the time of
registration

- ECOG performance status =< 1 (Karnofsky >= 70%)

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin = 9 g/dl

- Total bilirubin =<1.5 X institutional upper limit of normal

- AST (SGOT) & ALT (SGPT) =< 2.5 X institutional upper limit of normal or =< 5 X
institutional upper limit of normal if patient has liver metastasis

- Creatinine = 1.5 mg/dL OR creatinine clearance >= 60 mL/min/1.73 m2 for patients with
creatinine levels above institutional normal

- Other prior malignancy is allowed as long as the patient does not require active
treatment for their second malignancy and there is no radiographic evidence of second
malignancy; patients who are receiving hormonal therapy for breast or prostate cancer
as adjuvant treatment are eligible

- The effects of bortezomib on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because carboplatin, the other
therapeutic agent used in this trial, is known to be teratogenic, women of
child-bearing potential and men of reproductive potential must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation; should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately

- Ability to understand and the willingness to sign a written informed consent
document; written informed consent must be obtained prior to any evaluations being
performed solely for the purposes of screening for eligibility for this study

Exclusion Criteria:

- Patients who have only locally advanced disease (not metastatic) are excluded

- Patients who have received prior treatment with carboplatin, bortezomib, or another
proteasome inhibitor are excluded

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
events; however, brain imaging studies are not required to assess eligibility if the
patient has no neurological signs or symptoms

- Patients with current neurotoxicity, defined as greater than CTCAE Grade 1
neurotoxicity

- Patients must not be planning to receive any other concomitant anticancer treatment
including chemotherapy, radiation therapy, biologic agents, or any other
investigational drugs

- Patients must not have significant history of cardiac disease, i.e., unstable angina,
congestive heart failure with New York Heart Association class 3 or 4, and myocardial
infarction within the last 6 months

- Pregnant women are excluded from this study because bortezomib is a proteasome
inhibitor agent with the potential for teratogenic or abortifacient effects;
carboplatin has been shown to be embryotoxic and teratogenic in rats; because there
is an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with bortezomib and carboplatin, breastfeeding should be
discontinued if the mother is treated with these drugs

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with bortezomib and carboplatin; in
addition, these patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy; appropriate studies will be undertaken in patients
receiving combination antiretroviral therapy when indicated



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acinar Cell Adenocarcinoma of the Pancreas

Duct Cell Adenocarcinoma of the Pancreas

Stage IV Pancreatic Cancer

Intervention(s)

Drug: bortezomib

Drug: carboplatin

Other: laboratory biomarker analysis

Primary Outcome(s)

Overall Survival Rate at 6 Months [Time Frame: up to 6 months]

Secondary Outcome(s)

Overall Response Rate [Time Frame: Evaluated at end of every second 3 week cycle for response]

Secondary ID(s)

MDA-2006-0079

NCI-2012-02894

Source(s) of Monetary Support

Please refer to primary and secondary sponsors