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A Phase II Evaluation of SU11248 (Sunitinib Malate) (IND #74019, NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma

Phase 2
18 Years
Not Enrolling
Ovarian Clear Cell Cystadenocarcinoma, Recurrent Ovarian Epithelial Cancer

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Trial Information

A Phase II Evaluation of SU11248 (Sunitinib Malate) (IND #74019, NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma


I. To evaluate the anti-tumor activity of sunitinib malate in patients with persistent or
recurrent clear cell ovarian carcinoma.

II. To examine the nature and degree of toxicity of this drug in these patients.


I. To characterize the distribution of progression-free survival and overall survival of
patients treated with this drug.


I. To determine pro-angiogenic protein levels (e.g., angiogenin, soluble VCAM-I, bFGF, PDGF,
PlGF, VEGF, and HIF1-alpha) at baseline, before course 4, and after completion of treatment.

II. To identify changes in serum and plasma angiogenesis markers at baseline, during
treatment (course 4), and at progression.

III. To determine the association between changes in biomarkers and primary and secondary
clinical endpoints (e.g. clinical response or progression-free survival).

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks
in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are obtained for further laboratory studies.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Diagnosis of recurrent or persistent clear cell ovarian cancer, meeting 1 of the
following criteria:

- Primary tumor with ≥ 50% clear cell histomorphology

- Histologically confirmed recurrence with ≥ 50% clear cell histomorphology

- Tumors must be negative for expression of WT-1 antigen and estrogen receptor antigen
by IHC

- If the primary tumor had ≥ 50% clear cell histomorphology, a biopsy of the
recurrent or persistent tumor is not required

- If the primary tumor had < 50% clear cell histomorphology (or if slides of the
primary tumor are not available), a biopsy of the recurrent or persistent tumor
is required

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded)

- Each lesion must be ≥ 10 mm when measured by CT scan, MRI, or calipers by
clinical exam OR ≥ 20 mm when measured by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis when measured by CT scan or MRI

- Must have ≥ 1 "target lesion" to be used to assess response as defined by RECIST

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days after completion of radiotherapy

- Must have received one prior platinum-based chemotherapeutic regimen containing
carboplatin, cisplatin, or another organoplatinum compound for management of primary

- Initial treatment may have included intraperitoneal therapy, consolidation
therapy, or extended therapy administered after surgical or non-surgical

- Must have a platinum-free interval of < 12 months, have progressed during
platinum-based therapy, or have persistent disease after platinum-based therapy

- One additional cytotoxic regimen for management of recurrent or persistent
disease allowed

- No primary peritoneal or fallopian tube cancer

- No history or evidence of CNS disease, including primary brain tumor or brain
metastases, by physical exam

- Not eligible for a higher priority (e.g., Phase III) GOG clinical trial for the same
population, if one exists

- GOG performance status (PS) 0-2 (for patients who received one prior regimen) OR GOG
PS 0-1 (for patients who received 2 prior regimens)

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN (or ≤ 5 times ULN for patients with liver metastases)

- Urine protein < 1+ by urine dipstick OR < 1,000 mg by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study therapy

- No active infection requiring antibiotics except uncomplicated urinary tract

- No serious non-healing wound, ulcer, or bone fracture

- No significant traumatic injury within the past 28 days

- No active bleeding or pathological condition that carries a high risk of bleeding
(e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)

- No seizures not controlled with standard medical therapy

- No cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid
hemorrhage within the past 6months

- No clinically significant cardiovascular disease, including any of the following:

- Poorly controlled hypertension (e.g., systolic BP ≥ 140 mm Hg or diastolic BP ≥
90 mm Hg)

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade II (e.g., ischemic rest pain, minor tissue
loss, ulceration, or gangrene) according to NCI CTC criteria

- No QTc prolongation (> 500 msec)

- No clinically significant peripheral artery disease (e.g., claudication within the
past 6 months)

- No pre-existing thyroid abnormality for which thyroid function is unable to be
maintained in the normal range with medication

- History of hypothyroidism allowed provided patient is currently euthyroid

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No circumstance that does not permit completion of study therapy or required

- No concurrent amifostine

- Prior biologics allowed, with the exception of anti-angiogenic agents that target

- No prior non-cytotoxic therapy (e.g., VEGF inhibitors, including bevacizumab) for
management of recurrent or persistent disease

- No prior sunitinib malate

- No prior cancer treatment that would contraindicate study therapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
or radiotherapy

- At least 3 weeks since any other prior therapy directed at the malignant tumor,
including immunologic agents or tamoxifen

- At least 28 days since prior surgery and recovered

- More than 7 days since prior placement of vascular access device or core biopsy

- At least 7 days since prior and no concurrent potent CYP3A4 inhibitors

- At least 12 days since prior and no concurrent potent CYP3A4 inducers

- No concurrent therapeutic doses of Coumadin-derivative anticoagulants (e.g.,

- Warfarin administered at doses of ≤ 2 mg daily allowed for prophylaxis of

- Low molecular weight heparin allowed provided PT/INR ≤ 1.5

- No concurrent major surgical procedure

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response rate (complete and partial response)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

John Chan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Ovarian Clear Cell Cystadenocarcinoma
  • Recurrent Ovarian Epithelial Cancer
  • Cystadenocarcinoma
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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