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Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00397787
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Pancreatic Cancer
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Sunitinib Sunitinib malate Pancrelipase Ultrase Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete or partial response or stable disease at 6 weeks post-initiation of protocol treatment) as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: November 2006
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with progressive metastatic pancreatic adenocarcinoma treated with sunitinib malate.

Secondary

  • Determine the duration of response, progression-free survival, and overall survival of patients treated with this drug.
  • Determine the safety of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma

    • Metastatic disease
  • Must have evidence of disease progression after receiving 1 of the following prior first-line therapies:

    • One gemcitabine-containing treatment regimen for metastatic disease or a gemcitabine-containing cytotoxic combination
    • One gemcitabine-containing chemoradiotherapy regimen for inoperable locally advanced pancreatic cancer

      • Patients must have subsequently progressed and have measurable disease outside a radiation port
    • One adjuvant chemotherapy regimen or chemoradiotherapy containing gemcitabine

      • Patients must have subsequently progressed within 3 months of completion of adjuvant therapy and have measurable disease outside the radiation port
  • Measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan 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
  • No brain metastases
  • No evidence of duodenal invasion on CT scan

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin < 1.5 mg/dL
  • AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • PT and PTT ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • History of hypothyroidism allowed provided patient is currently euthyroid
  • No QTc prolongation (i.e., QTc interval ≥ 500 msec) or other significant EKG abnormalities
  • No New York Heart Association (NYHA) class III or IV heart failure within the past 12 months
  • No history of hypertension (i.e., blood pressure ≥ 140/90 mm Hg) unless well controlled and on antihypertensive therapy
  • No cardiac disease within the past 12 months, including any of the following:

    • Myocardial infarction
    • Cardiac arrhythmia
    • Stable or unstable angina
    • Symptomatic congestive heart failure
    • Coronary or peripheral artery bypass graft or stenting
  • No cerebrovascular accident or transient ischemic attack within the past 12 months
  • No pulmonary embolism within the past 6 months
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of any of the following diseases within the past 6 months:

    • Significant bleeding events (e.g., upper or lower gastrointestinal [GI] bleeding, hemoptysis, or hematuria)
    • Abdominal fistula
    • GI perforation
  • No intra-abdominal abscess within the past 28 days
  • No currently active second malignancy except nonmelanoma skin cancer

    • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior erlotinib hydrochloride allowed
  • No prior therapy with any other antiangiogenic agent, including any of the following:

    • Bevacizumab
    • Sorafenib
    • Pazopanib
    • AZD2171
    • Vatalanib
    • VEGF Trap
  • At least 4 weeks since prior chemotherapy and/or radiotherapy and recovered
  • At least 4 weeks since prior major surgery and recovered
  • More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

    • Azole antifungals (e.g., ketoconazole, itraconazole)
    • Diltiazem
    • Clarithromycin
    • Erythromycin
    • Verapamil
    • Delavirdine
    • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
  • More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • Hypericum perforatum (St. John's wort)
    • Efavirenz
    • Tipranavir
  • No concurrent agents with proarrhythmic potential, including any of the following:

    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No concurrent therapeutic doses of warfarin-derived anticoagulants

    • Warfarin at doses ≤ 2 mg/day for prophylaxis of thrombosis or low molecular weight heparin for patients with a PT/INR < 1.5 allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397787

  Show 91 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Eileen O'Reilly, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
O'Reilly EM, Niedzwiecki D, Hollis DR, et al.: A phase II trial of sunitinib (S) in previously-treated pancreas adenocarcinoma (PAC), CALGB 80603. [Abstract] J Clin Oncol 26 (Suppl 15): A-4515, 2008.

Study ID Numbers: CDR0000511035, CALGB-80603
Study First Received: November 9, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00397787  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Disease Progression
Endocrine System Diseases
Pancrelipase
Recurrence
Digestive System Diseases
Sunitinib
Neoplasm Metastasis
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009