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A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer


PRIMARY OBJECTIVES:

I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and
carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic
cancer.

SECONDARY OBJECTIVES:

I. To evaluate the objective tumor response rate, the duration of response, time to tumor
progression, and overall survival.

II. To evaluate biological effects on peripheral blood mononuclear cells. III. To evaluate
the safety profile of this combination. IV. To evaluate archival tissue for
epithelial-to-mesenchymal transition (EMT) and E-cadherin and Zeb-1.

OUTLINE:

Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11 and carboplatin
intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Rate at 6 Months

Outcome Description:

Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.

Outcome Time Frame:

up to 6 months

Safety Issue:

No

Principal Investigator

Gauri Varadhachary

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Network

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02894

NCT ID:

NCT00416793

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

MD Anderson Cancer NetworkHouston, Texas  77030