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Sunitinib in Treating Patients With Unresectable, Locally Advanced or Metastatic Cervical Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Cancer Institute of Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00389974
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with unresectable, locally advanced or metastatic cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate Tyrosine Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma

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

Primary Outcome Measures:
  • Objective response (partial and complete) as measured by RECIST criteria for at least 4 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the efficacy, in terms of objective response rate, of sunitinib malate in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
  • Assess the toxicity of this drug in these patients.
  • Determine time to progression, early objective progression rate, objective response, and response duration in patients treated with this drug.

OUTLINE: This is a multicenter, nonrandomized study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients with responding disease receive 2 courses beyond complete response or stable partial response.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed carcinoma of the cervix, including any of the following subtypes:

    • Squamous cell carcinoma
    • Adenosquamous carcinoma
    • Adenocarcinoma
  • Meets 1 of the following criteria:

    • Unresectable, locally advanced disease
    • Metastatic disease
    • Recurrent or persistent disease unsuitable for curative treatment by surgery and/or radiotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • Measurable disease must be present outside previously irradiated area

      • Patients whose sole site of disease is in a previously irradiated area are not eligible unless there is evidence of disease progression or new lesions have been documented in the irradiated field* NOTE: *Exceptions may be made for low-dose palliative radiotherapy
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 100,000/mm^3
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Calcium ≤ 3 mmol/L
  • Creatinine normal OR creatinine clearance ≥ 60mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be accessible for treatment, response assessment, and follow-up
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or any other curatively treated solid tumor
  • No known history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
  • No QTc prolongation (i.e., QTc interval ≥ 500 msec) or other significant ECG abnormalities
  • No history of New York Heart Association (NYHA) class III or IV heart failure
  • No history of NYHA class II cardiac function unless both of the following criteria are met:

    • Asymptomatic with respect to cardiac function
    • LVEF > LLN by MUGA within the past 14 days
  • No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
  • None of the following within the past year:

    • Myocardial infarction
    • Cardiac arrhythmia
    • Stable/unstable angina
    • Symptomatic congestive heart failure
    • Pulmonary embolism
    • Cerebrovascular accident or transient ischemic attack
  • No bowel obstruction or any other condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain sunitinib malate
  • No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following:

    • History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to obtain consent
    • Active uncontrolled infection
    • Any other medical conditions that might be aggravated by treatment
    • Serious or non-healing wound, ulcer, or bone fracture
    • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No pre-existing hypothyroidism except euthyroid on medication
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

  • Prior neoadjuvant or adjuvant chemotherapy allowed
  • Prior chemoradiotherapy allowed
  • Prior radiotherapy allowed, including external beam and/or intracavity radiotherapy

    • No prior radiotherapy to ≥ 30% of functioning bone marrow
  • At least 28 days since prior major surgery and recovered
  • At least 28 days since prior chemotherapy and recovered
  • At least 28 days since prior radiotherapy and recovered
  • No more than 1 prior chemotherapy regimen for recurrent metastatic disease
  • No prior antiangiogenic agents or multitargeted tyrosine kinase inhibitors (e.g., bevacizumab, sorafenib tosylate, pazopanib, thalidomide, AZD2171, vandetanib, AMG706, vatalanib, or VEGF Trap)
  • No prior surgical procedures affecting absorption
  • No prior anthracycline exposure or central thoracic radiotherapy that included the heart in the radiation port unless both of the following criteria are met:

    • Asymptomatic with respect to cardiac function
    • LVEF > lower limit of normal (LLN) by MUGA within the past 14 days
  • No coronary/peripheral artery bypass graft or stenting within the past year
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

    • Azole antifungals (e.g., ketoconazole or itraconazole)
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
    • Delavirdine
  • At least 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 combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic coumadin-derivative anticoagulants (e.g., warfarin) except for doses ≤ 2 mg per day for prophylaxis of thrombosis

    • Low molecular weight heparin allowed provided INR ≤ 1.5
  • No concurrent agents with proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No other concurrent anticancer therapy, including other investigational anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389974

Locations
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H3G 1Y6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Helen J. Mackay, MD Princess Margaret Hospital, Canada
  More Information

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

Study ID Numbers: CDR0000509467, CAN-NCIC-IND184
Study First Received: October 18, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00389974  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer

Study placed in the following topic categories:
Epidermoid carcinoma
Sunitinib
Squamous cell carcinoma
Carcinoma, squamous cell
Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Recurrence
Carcinoma

Additional relevant MeSH terms:
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009