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Trial record 9 of 21 for:    "Acinar Cell Carcinoma" | "Immunosuppressive Agents"

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

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ClinicalTrials.gov Identifier: NCT00397787
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE November 10, 2006
Last Update Posted Date June 4, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Response (CR/PR/stable disease) as measured by RECIST criteria [ Time Frame: At 6 weeks post-initiation of protocol treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
Response (complete or partial response or stable disease at 6 weeks post-initiation of protocol treatment) as measured by RECIST criteria
Change History Complete list of historical versions of study NCT00397787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Response duration [ Time Frame: Up to 2 years ]
    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.
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.
  • 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 [ Time Frame: Up to 2 years ]
    Summarized descriptively for all patients receiving at least one dose of sunitinib.
  • Overall survival (OS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
  • Response duration
  • Progression-free survival
  • Toxicity
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine
Official Title  ICMJE 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
Brief 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.
Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
Intervention  ICMJE Drug: sunitinib malate
Given PO
Other Names:
  • SU11248
  • sunitinib
  • Sutent
Study Arms  ICMJE Experimental: Treatment (sunitinib malate)
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: sunitinib malate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2006)
64
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
    • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00397787
Other Study ID Numbers  ICMJE NCI-2012-02823
CALGB-80603
U10CA031946 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eileen O'Reilly Cancer and Leukemia Group B
PRS Account National Cancer Institute (NCI)
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP