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A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma


- Determine the efficacy, in terms of response rate, of sunitinib malate in patients with
advanced or metastatic recurrent ovarian epithelial, fallopian tube, or primary
peritoneal carcinoma.

- Determine the toxicity of this regimen in these patients.

- Document CA125 response rate, early objective progression rate, and response duration.

OUTLINE: This is a nonrandomized, open label, multicenter study.

Patients receive oral sunitinib once daily on days 1-28. Treatment repeats every 28 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed diagnosis of 1 of the following:

- Ovarian epithelial cancer

- Fallopian tube cancer

- Primary peritoneal cancer

- Advanced and/or metastatic disease incurable by standard therapies

- Must have received at least 1 but no more than 2 prior chemotherapy regimens* (1 must
have been platinum-containing) AND may be either platinum-sensitive or
platinum-resistant NOTE: *Switching from 1 platinum compound to another for reasons
of disease progression or failure to respond is considered a second regimen; the same
regimen given as first- and second-line therapy is also considered 2 regimens

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan

- Patients with CA125 as only evidence of disease are not eligible

- Measurable disease must be outside of a previously irradiated area

- Sole site of disease in a previously irradiated area is not allowed unless there
is evidence of disease progression or new lesions were documented in the
irradiated field

- No known brain metastases


- ECOG performance status 0-1

- Life expectancy ≥ 12 weeks

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Calcium ≤ 3 mmol/L

- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer, curatively treated in situ cancer of the cervix, or other curatively
treated solid tumors

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to sunitinib malate

- No QTc prolongation, defined as QTc interval ≥ 500 msec, or other significant ECG

- No New York Heart Association (NYHA) class III-IV heart failure

- History of NYHA class II heart failure allowed provided both of the following
criteria are met:

- Asymptomatic with respect to cardiac function

- LVEF > lower limit of normal as assessed by MUGA at baseline

- No poorly controlled hypertension (systolic blood pressure [BP] ≥ 140 mm Hg or
diastolic BP ≥ 90 mm Hg)

- No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or
symptomatic congestive heart failure within the past year

- No pulmonary embolism within the past year

- No cerebrovascular accident or transient ischemic attack within the past year

- No bowel obstruction or any other condition (e.g., gastrointestinal [GI] 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 tablets

- No serious illness or medical condition, including, but not limited to, any of the

- History of significant neurologic or psychiatric disorder that would preclude
study compliance

- Active uncontrolled infection

- Other medical conditions that would be aggravated by treatment

- Serious or nonhealing wound, ulcer, or bone fracture

- Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28

- No preexisting hypothyroidism unless euthyroid on medication

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- See Disease Characteristics

- No more than 1 prior hormonal treatment for metastatic disease

- No prior surgical procedures affecting absorption

- No prior antiangiogenic agents or multitargeted tyrosine kinase inhibitors (e.g.,
bevacizumab, sorafenib, pazopanib, thalidomide, ZD6474, AMG 706, AZD2171, vatalanib,
or VEGF Trap)

- No prior anthracycline exposure or thoracic radiotherapy that included the heart in
the radiotherapy port, unless all of the following criteria are met:

- Asymptomatic with respect to cardiac function

- LVEF > lower limit of normal as assessed by MUGA at baseline

- At least 1 year since prior coronary/peripheral artery bypass graft or stenting

- At least 28 days since prior hormonal therapy

- At least 28 days since prior chemotherapy and recovered

- At least 28 days since prior radiotherapy and recovered

- Radiotherapy must have involved < 30% of functioning bone marrow

- At least 28 days since prior major surgery and recovered

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the

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

- Erythromycin

- Diltiazem

- Verapamil

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

- Delavirdine

- Clarithromycin

- 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 agents with proarrhythmic potential, including any of the following:

- Terfenadine

- Quinidine

- Procainamide

- Disopyramide

- Sotalol

- Probucol

- Bepridil

- Haloperidol

- Risperidone

- Indapamide

- Flecainide

- No concurrent therapeutic coumarin-derivative anticoagulants (e.g., warfarin)

- Warfarin (≤ 2 mg/day) allowed for prophylaxis of thrombosis

- Concurrent low molecular weight heparin allowed provided INR ≤ 1.5

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy or other investigational agents

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 as assessed by RECIST criteria

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

James Biagi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Centre of Southeastern Ontario at Kingston General Hospital


Canada: Health Canada

Study ID:




Start Date:

January 2007

Completion Date:

January 2012

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial