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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00397787
First received: November 9, 2006
Last updated: June 3, 2013
Last verified: June 2013
  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. 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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response (CR/PR/stable disease) as measured by RECIST criteria [ Time Frame: At 6 weeks post-initiation of protocol treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Summarized descriptively for all patients receiving at least one dose of sunitinib.

  • Overall survival (OS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.


Enrollment: 64
Study Start Date: November 2006
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397787

Locations
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
Investigators
Principal Investigator: Eileen O'Reilly Cancer and Leukemia Group B
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00397787     History of Changes
Other Study ID Numbers: NCI-2012-02823, CALGB-80603, U10CA031946
Study First Received: November 9, 2006
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Acinar Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on August 01, 2014