Acinar Cell Adenocarcinoma of the PancreasPhase 2NCT00416793
Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing bortezomib, carboplatin and laboratory biomarker analysis in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer
- What is being tested?
- bortezomib, carboplatin and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with carboplatin may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer
- Being tested
- bortezomib, carboplatin, laboratory biomarker analysis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Given IV
carboplatinDrug
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: bortezomib; Drug: carboplatin; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate at 6 Months
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.
Measured: up to 6 months
Secondary outcomes (1)
Overall Response Rate
Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.
Measured: from assignment of treatment until the date of first documented progression, assessed up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Study was terminated due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acinar Cell Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gauri Varadhachary, Principal investigator, MD Anderson Cancer Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416793
- Sponsor's protocol ID
- NCI-2012-02894
- Other IDs
- NCI-2012-02894, CDR0000522739, NO1-CM-17003-74, MDA-2006-0079, 7752
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2006
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00416793
- Acronym / sponsor ID
- NCI-2012-02894
- Conditions
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Stage IV Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to poor accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2006 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Posted 15 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with carboplatin may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: bortezomib, Drug: carboplatin, Other: laboratory biomarker analysisPatients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibGiven IV | Drug | Treatment |
| carboplatinGiven IV | Drug | Treatment |
| laboratory biomarker analysisCorrelative studies | Other | Treatment |
Primary outcome
Overall Survival Rate at 6 Months
Time frame: up to 6 months
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.
1 secondary outcome
Overall Response Rate
Time frame: from assignment of treatment until the date of first documented progression, assessed up to 17 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauri Varadhachary principal investigator
MD Anderson Cancer Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, carboplatin and laboratory biomarker analysis in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Rate at 6 Months (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.