AzTrials
AzTrials

Acinar Cell Adenocarcinoma of the PancreasPhase 2NCT00397787

Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

A Phase 2 study testing sunitinib malate in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sunitinib malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesUnited States
Study dates
Nov 2006to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of disease progression following first-line therapy is required
  • No brain metastases
  • Patients with measurable disease
  • Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded as >= 20 mm with conventional techniques or as>= 10 mm with spiral computed tomography (CT) scan; of particular note, the primary pancreatic tumor does not constitute measurable disease; therefore, patients with locally advanced pancreatic cancer as the sole site of disease are not eligible
  • Patients must have received one of the following prior therapies containing gemcitabine:
  • One and only one prior therapy for metastatic disease with gemcitabine, or a gemcitabine-containing cytotoxic combination, or
Show all 53Show fewer
  • One prior chemoradiation therapy containing gemcitabine for inoperable locally advanced pancreatic cancer, as long as the patient has subsequently progressed and has measurable disease outside a radiation port, or
  • One prior adjuvant chemotherapy regimen or chemoradiation therapy containing gemcitabine if the patient subsequently progressed within 3 months of completion of adjuvant therapy; patients who have received chemoradiation in the adjuvant setting must have measurable disease outside the radiation port
  • No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.)
  • At least 4 weeks must have elapsed prior to initiation of treatment since the completion of chemotherapy and/or radiation therapy
  • At least 4 weeks must have elapsed prior to registration since any major surgery
  • Prior erlotinib is permitted; the last dose must have been administered 14 or more days prior to initiation of treatment; all erlotinib related side effects must have resolved to < grade 1 prior to registration
  • No significant cardiac disease including:
  • QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant EKG abnormalities
  • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to registration
  • History of class III or IV heart failure within 12 months prior to registration as defined by the NYHA functional classification system
  • In addition, patients with history of hypertension must be well controlled (< 140/90) on a regimen of anti-hypertensive therapy
  • Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
  • The use of inhibitors and inducers of CYP3A4 is not permitted:
  • The following inhibitors of CYP3A4 is prohibited within 7 days before beginning and during treatment with sunitinib:
  • Azole antifungals (ketoconazole, itraconazole)
  • Diltiazem
  • Clarithromycin
  • Erythromycin
  • Verapamil
  • Delavirdine
  • HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
  • The following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib:
  • Rifampin
  • Rifabutin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • St. John's wort
  • Efavirenz
  • Tipranavir
  • Other inhibitors or inducers of CYP3A4 may be used if necessary, but their use is discouraged
  • The use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide) is not permitted during the study
  • ECOG performance status 0-2
  • No history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration
  • No history of pulmonary embolism within the past 6 months
  • Patients who require use of therapeutic doses of coumadin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's PT INR is < 1.5
  • No serious or non-healing wound, ulcer, or bone fracture
  • No history (within 6 months) of significant bleeding events (e.g., upper or lower GI bleeding, hemoptysis, or hematuria), abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
  • No evidence of duodenal invasion by the tumor on CT scan
  • No "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • Non-pregnant and not breast feeding; pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate
  • ANC >= 1,500/μl
  • Platelet count >= 100,000/μl
  • Bilirubin < 1.5 mg/dL
  • PT and PTT =< 1.5 X ULN
  • Creatinine =< 1.5 mg/dL
  • AST (SGOT) =< 2.5 X ULN if no liver metastases (=< 5 X ULN if liver metastases)

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy

This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

  1. To determine the duration of response, progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

II. To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

OUTLINE: This is a multicenter, nonrandomized study.

Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed every 3 months until 2 years from study entry or until disease progression.

Being tested
sunitinib malate
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • sunitinib malateDrug

    Also called SU11248, sunitinib, Sutent

    Given PO

Study groups in NCT00397787
Study groupRoleWhat they receive
Treatment (sunitinib malate)ExperimentalPatients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sunitinib malate

What is being measured

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

  1. Response (CR/PR/stable disease) as measured by RECIST criteria

    Measured: At 6 weeks post-initiation of protocol treatment

Secondary outcomes (4)

  1. Response duration

    Duration of response will be determined for the subset of patients who achieve a confirmed response of CR or PR. Duration of objective response will be defined as the time from the first tumor assessment indicating response (later confirmed) to the time of disease progression or death from any cause.

    Measured: Up to 2 years

  2. Progression-free survival (PFS)

    Median and 1-year survival will be assessed using Kaplan-Meier methods.

    Measured: Up to 2 years

  3. Number and percentage of patients reporting common and serious adverse events (AEs), the AEs related to sunitinib, reason for study discontinuation, clinically significant laboratory abnormalities, and AEs with worst NCI CTCAE grade

    Summarized descriptively for all patients receiving at least one dose of sunitinib.

    Measured: Up to 2 years

  4. Overall survival (OS)

    Median and 1-year survival will be assessed using Kaplan-Meier methods.

    Measured: Up to 2 years

Timeline

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

  1. First posted10 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionSep 2007

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00397787
Sponsor's protocol ID
NCI-2012-02823
Other IDs
CALGB-80603, U10CA031946
Status last verified
Jun 2013
First submitted
9 Nov 2006
Last updated
4 Jun 2013
Results posted
No

Publications

  • O'Reilly EM, Niedzwiecki D, Hall M, Hollis D, Bekaii-Saab T, Pluard T, Douglas K, Abou-Alfa GK, Kindler HL, Schilsky RL, Goldberg RM; Cancer and Leukemia Group B. A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603). Oncologist. 2010;15(12):1310-9. doi: 10.1634/theoncologist.2010-0152. Epub 2010 Dec 10.

    PubMed 21148613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by National Cancer Institute (NCI) at 2 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 53 inclusion and 0 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response (CR/PR/stable disease) as measured by RECIST criteria (time frame: At 6 weeks post-initiation of protocol treatment). 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 NCT00397787, which also lists 1 linked publication.

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 4 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in