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Trial record 7 of 20 for:    "Acinar Cell Carcinoma" | "Antimetabolites"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397787
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer Drug: sunitinib malate Phase 2

Detailed Description:


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


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2006
Actual Primary Completion Date : September 2007

Arm Intervention/treatment
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.
Drug: sunitinib malate
Given PO
Other Names:
  • SU11248
  • sunitinib
  • Sutent

Primary Outcome Measures :
  1. Response (CR/PR/stable disease) as measured by RECIST criteria [ Time Frame: At 6 weeks post-initiation of protocol treatment ]

Secondary Outcome Measures :
  1. 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.

  2. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.

  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 [ Time Frame: Up to 2 years ]
    Summarized descriptively for all patients receiving at least one dose of sunitinib.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397787

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United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Eileen O'Reilly Cancer and Leukemia Group B

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00397787     History of Changes
Other Study ID Numbers: NCI-2012-02823
U10CA031946 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Pancreatic Neoplasms
Carcinoma, Acinar Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors