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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

Phase 2
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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


- 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

- 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 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

- Azole antifungals (e.g., ketoconazole or itraconazole)

- Clarithromycin

- Erythromycin

- Diltiazem

- Verapamil

- HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or

- Delavirdine

- At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (partial and complete) as measured by RECIST criteria for at least 4 weeks

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Helen J. Mackay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

January 2007

Completion Date:

January 2011

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms