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Pancreatic Acinar Cell CarcinomaPhase 2NCT01280058

Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

A Phase 2 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Pancreatic Acinar Cell Carcinoma and Pancreatic Ductal Adenocarcinoma, run by National Cancer Institute (NCI) at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well carboplatin and paclitaxel with or without viral therapy works in treating patients with pancreatic cancer that has come back or has spread to other places in the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Laboratory Biomarker Analysis and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
6 sitesUnited States
Study dates
Dec 2010to 20 Jan 2016
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

  • Histologically confirmed adenocarcinoma of the pancreas that is recurrent or metastatic; cytological confirmation is not allowed on this study; paraffin embedded tissue from tumor blocks will be required from patients before enrolling on this study; diagnosis of pancreas cancer with histologic confirmation of adenocarcinoma would suffice
  • Patients must have measurable disease, defined as one lesion that can be accurately measured in at least one dimension per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (longest diameter to be recorded) as >= 10 mm by spiral computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm); malignant lymph nodes will be considered measurable if they are >= 15 mm in short axis; for patients previously irradiated, the measurable lesion must be outside the radiated field
  • Patients must not have received any prior chemotherapy in metastatic setting; patients who have received prior chemotherapy in the adjuvant setting will not be eligible for our study; patients should not have received prior Reolysin; prior palliative radiation therapy or major surgery must have occurred at least 28 days prior to study enrollment; prior minor surgeries (such as laparoscopies) must have occurred at least 14 days prior to study enrollment; prior minor procedures such as biopsies and mediport placement must have occurred at least 48 hours prior to study enrollment
  • Eastern Cooperative Oncology Group (ECOG) status =< 1 (Karnofsky >= 70%)
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L International System of Units (SI) units
  • Platelet count >= 100 x10^9/L SI units
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  • Hemoglobin >= 8.5 g/dL SI units
  • Serum creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min
  • Bilirubin =< upper limit of normal (ULN) (=< 2 x ULN if it is non-rising for a period of 10 days prior to initiation of therapy)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 X ULN
  • Troponin I < ULN
  • All patients must have signed an informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
  • Women of child-bearing potential and men 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; patients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals while on study and for >= 3 weeks following the last dose of Reolysin administration
  • All patients must be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests

Who cannot join

  • Patients may not be receiving any other investigational agents or concurrent therapy with other anti-cancer agents while on study
  • Patients with untreated brain metastases will be excluded from this clinical trial; however, patients with resected oligometastasis are eligible if postresection magnetic resonance imaging (MRI) demonstrates resolution; gamma-knife treated patients are also eligible if there are no more than two treated metastases confined to the same area of the brain and a post treatment MRI shows a decrease in the metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Reolysin or other agents used in the study
  • Patients may not have received any viral-based therapy within the past 6 months
  • Patients must have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures; all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, version [v.] 4 ) grade =< 1 prior to study enrollment
  • Patients must not have grade 2 or higher baseline peripheral neuropathy according to CTCAE v. 4
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  • Patients with uncontrolled cardiac dysfunction or arrhythmia, including a myocardial infarction in the preceding 6 months, known cardiac ejection fraction < 40%, symptomatic congestive heart failure, or unstable angina pectoris
  • Patients must not be receiving concurrent systemic immunosuppressive therapy
  • Patients must not have known human immunodeficiency virus (HIV) infection or active hepatitis B or C
  • Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or known psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not have dementia or altered mental status that would prohibit informed consent
  • Patients must not have other known severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, study drug administration, or may interfere with the interpretation of study results that, in the judgment of the Principal Investigator, would make the patient inappropriate for this study
  • Pregnant women are excluded from this study; breastfeeding should be discontinued while the mother is being treated with the agents in this clinical trial

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel Plus Reovirus Serotype-3 Dearing Strain (Reolysin) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients With Recurrent or Metastatic Pancreatic Cancer

This phase II trial studies how well carboplatin and paclitaxel with or without viral therapy works in treating patients with pancreatic cancer that has come back or has spread to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Viral therapy may be able to kill tumor cells without damaging normal cells. It is not yet known whether carboplatin and paclitaxel are more effective with or without viral therapy in treating pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the improvement in progression-free survival with Reolysin (wild-type reovirus), carboplatin, and paclitaxel relative to carboplatin and paclitaxel alone in patients with recurrent or metastatic pancreatic cancer.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and tolerability of Reolysin in combination with carboplatin and paclitaxel versus without Reolysin in patients with recurrent or metastatic pancreas cancer.

II. To compare the treatment groups for other efficacy endpoints such as overall response rate and overall survival.

III. To define how the combination of Reolysin and carboplatin and paclitaxel (CP) modulate factors regulating immunity to reovirus and its persistence in the system circulation of patients with pancreatic cancer.

IV. To prospectively establish and validate the relationship between Ras mutations in tumor samples and response to Reolysin.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

After completion of study treatment, patients are followed up at 1 month and then every 2 months thereafter.

Being tested
Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Wild-type Reovirus
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Wild-type ReovirusBiological

    Also called Reolysin

    Given IV

Study groups in NCT01280058
Study groupRoleWhat they receive
Arm I (wild-type reovirus, carboplatin, paclitaxel)ExperimentalPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Wild-type Reovirus
Arm II (carboplatin, paclitaxel)ExperimentalPatients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival Using RECIST v. 1.1

    The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.

    Measured: From study entry to the date of documented progression and/or death, assessed up to 4 years

Secondary outcomes (3)

  1. Incidence of Severe (Grade 3+) Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment, as Assessed by NCI CTCAE Version 4.0

    Toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.

    Measured: Up to 4 years

  2. Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1

    95% confidence intervals will be calculated. Differences in objective response rates between the treatment arms will be assessed using Fisher's exact test.

    Measured: Up to 4 years

  3. Overall Survival

    Evaluated and compared between the two treatment groups using log-rank statistics and graphically using the methods of Kaplan and Meier.

    Measured: From study entry to the time of death due to any cause, assessed up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completion19 Jan 2016
  4. Study completion20 Jan 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01280058
Sponsor's protocol ID
NCI-2011-02567
Other IDs
NCI-2011-02567, OSU 10045, OSU-10045, CDR0000692060, 8601, 8601, N01CM00070, N01CM62207
Status last verified
Feb 2018
First submitted
18 Jan 2011
Last updated
9 Mar 2018
Data monitoring committee
No

Publications

  • Noonan AM, Farren MR, Geyer SM, Huang Y, Tahiri S, Ahn D, Mikhail S, Ciombor KK, Pant S, Aparo S, Sexton J, Marshall JL, Mace TA, Wu CS, El-Rayes B, Timmers CD, Zwiebel J, Lesinski GB, Villalona-Calero MA, Bekaii-Saab TS. Randomized Phase 2 Trial of the Oncolytic Virus Pelareorep (Reolysin) in Upfront Treatment of Metastatic Pancreatic Adenocarcinoma. Mol Ther. 2016 Jun;24(6):1150-1158. doi: 10.1038/mt.2016.66. Epub 2016 Apr 4.

    PubMed 27039845

  • Farren MR, Mace TA, Geyer S, Mikhail S, Wu C, Ciombor K, Tahiri S, Ahn D, Noonan AM, Villalona-Calero M, Bekaii-Saab T, Lesinski GB. Systemic Immune Activity Predicts Overall Survival in Treatment-Naive Patients with Metastatic Pancreatic Cancer. Clin Cancer Res. 2016 May 15;22(10):2565-74. doi: 10.1158/1078-0432.CCR-15-1732. Epub 2015 Dec 30.

    PubMed 26719427

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Pancreatic Acinar Cell Carcinoma and Pancreatic Ductal Adenocarcinoma, run by National Cancer Institute (NCI) at 6 sites 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 14 inclusion and 13 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: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 7 Feb 2018). 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?

Progression-free Survival Using RECIST v. 1.1 (time frame: From study entry to the date of documented progression and/or death, assessed up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01280058, which also lists 2 linked publications.

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 9 Mar 2018.

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