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Evaluation of the Efficacy of Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma

Phase 2
20 Years
80 Years
Open (Enrolling)
Ovarian Cancer, Adverse Effects

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Trial Information

Evaluation of the Efficacy of Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma

Ovarian cancer is the 10th leading cancer in women in Taiwan. There were 894 new cases in
2004 and 297 women died of ovarian cancer in 2001 according to the data released by the
Department of Health. The incidence of epithelial ovarian cancer increases with age and the
median age at the time of diagnosis is 63 years, and 70% of patients present with advanced

Primary treatment for ovarian cancer consists of appropriate surgical staging and
cytoreductive surgery, followed in most patients by systemic chemotherapy. Initial surgery
should be a comprehensive staging laparotomy. For patients with clinical stage III or IV
disease, the usual recommendation continues to be maximally cytoreductive surgery followed
by adjuvant chemotherapy.

Most patients with epithelial ovarian cancer will receive postoperative systemic
chemotherapy. Observation is recommended for stage Ia, grade 1 tumors, owing to their high
cure rate. For patients with higher-grade and/or higher-stage tumors, systemic chemotherapy
is indicated. The recommendation for specific primary chemotherapy/primary adjuvant therapy
is Paclitaxel plus platinum regimens. Paclitaxel plus cisplatin or carboplatin are the
recommended regimens. The extent of treatment varies with stage of disease. For patients
with advanced-stage disease, six cycles of chemotherapy are recommended, whereas for
earlier-stage disease, three to six cycles are recommended, pending the results of ongoing
studies in this group of patients.

Treatment of relapsed ovarian cancer Despite the high objective response rate associated
with primary platinum/taxane-based chemotherapy in advanced ovarian cancer, the majority of
patients will eventually experience disease recurrence and be potential candidates for a
second-line treatment approach. Treatment options for relapsed cancer are numerous. Patients
with platinum-sensitive tumors (response to initial platinum therapy with no relapse for at
least 6 months) may be retreated with platinum agents and/or taxanes upon relapse.

Clear cell carcinomas of the ovary comprise approximately 5% of all ovarian neoplasms and
exhibit unique features including a more aggressive clinical course and more malignant
behavior. Clinically, clear cell carcinomas often present as a large pelvic mass, the
majority of which are detected at an early stage (FIGO stage I). Despite the early stage
diagnosis, survival rates are significantly lower for women with clear cell carcinoma
relative to stage-matched serous adenocarcinoma of the ovary. Furthermore, tumors are more
chemoresistant, resulting in a high degree of recurrence and exhibit more frequent early
metastasis to lymph nodes and parenchymal organs.

Sunitinib is a small molecule with anti-tumor properties pharmacologically mediated through
inhibition of multiple receptor tyrosine kinase (RTKs), which are important regulators of
tumor cell growth, angiogenesis, and metastasis. Specifically, sunitinib is a potent
ATP-competitive inhibitor of the catalytic activity of a group of closely related RTKs
consisting of VEGFR-1, -2, and -3, PDGFR-α and -β, KIT, CSF-1R, FLT-3, and RET. Due to its
multi-targeted profile, the pharmacological activity of sunitinib is likely mediated by
inhibition of multiple RTK targets and multiple pathways.

In this study, we would like to evaluated the effect of Sunitinib in recurrent / persisted
ovarian clear cell carcinoma.

Inclusion Criteria:

1. Histologically (Primary tumor with ≥ 50% clear cell histomorphology) or cytologically
confirmed ovarian clear cell carcinoma The disease should be documented recurrence or
resistant to primary platinum and paclitaxel based adjuvant chemotherapy.

- Patients are relapsed, not amenable to curative surgery or radiotherapy.

- not considered to required palliative chemotherapy nor radiotherapy

- Abnormal elevated serum CA125 tumor marker for no measurable disease by physical
examination or image study, roentgenogram or computed tomography (CT) scan.
Serum level of CA125 is higher than 80 IU/ml, or serum level of CA125 is at
least 2 fold on day 14 than original serum level of CA125 which is higher than
35 IU/ml but less than 80 IU/ml on day 0.

2. Evidence of measurable disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST) guidelines.

3. Female, 20 years of age or older.

4. GOG performance status of 0 - 2.

- GOG performance status 0-2

- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or
surgery to NCI CTCAE grade ≤1(except for alopecia).

- Life expectancy of at least 8 weeks

5. Adequate organ function as defined by the following criteria:

- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x
upper limit of normal (ULN) or AST and ALT ≤5 x ULN if liver function
abnormalities are due to underlying malignancy (liver metastases)

- Total serum bilirubin ≤1.5 x ULN

- Absolute neutrophil count (ANC) ≥1500/µL

- Platelets ≥100,000/µL

- Hemoglobin ≥9.0 g/dL

- Serum creatinine ≤1.5 x ULN

- QTc interval ≤450 msec for males and ≤470 msec for females (based on a mean
value from 3 ECGs)

- Left ventricular ejection fraction (LVEF) ≥lower limit of institutional normal
(LLN) as assessed by multigated acquisition (MUGA) scan or echocardiogram

6. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment.

7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

Exclusion Criteria:

1. Any of the following: known, severe hypersensitivity to sunitinib or any of the
excipient of this product, unable to swallow sunitinib, previous treatment with

2. Major surgery or radiation therapy within 4 weeks of study treatment.

3. Evidence of tumor bleeding within 4 weeks of study treatment.

4. NCI CTCAE grade ≥3 hemorrhage within 4 weeks of study treatment.

5. Newly diagnosed CNS metastases that have not been adequately controlled

6. Ongoing cardiac dysrhythmias of grade ≥2.

7. Hypertension that cannot be controlled by medication (>150/100 mmHg despite optimal
medical therapy).

8. Any of the following within the 12 months prior to study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
congestive heart failure, cerebrovascular accident including transient ischemic
attack, or pulmonary embolism.

9. Diagnosis of any second malignancy within the last 3 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
treated with no evidence of recurrent disease for 12 months.

10. Ongoing treatment with therapeutic doses (with therapeutic INR levels) of coumarin
derivatives (low dose up to 2 mg PO daily for deep vein thrombosis prophylaxis is
allowed) or oral anti-vitamin K agents.

11. PT >1.5 x ULN

12. Known human immunodeficiency virus (HIV) infection.

13. Current treatment on another clinical trial.

14. Pregnancy or breastfeeding. Patients who are unwilling or unable to use adequate
contraception to prevent pregnancy during the study. All female patients with
reproductive potential must have a negative pregnancy test prior to study entry.

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Description:

The tumor response will be assessed according to World Health Organization (WHO) response criteria or Rustin's criteria: Complete response (CR) Complete disappearance of all clinically detectable lesions for a minimum of 4 weeks. Clinical condition and performance status remains stable or improve. Partial response (PR) 50% or more decrease in the sum of the products of perpendicular diameters of all measurable lesions or tumor marker-CA125 for a minimum of 4 weeks. Clinical condition and performance status remains stable or improve. Stable disease (SD) A decrease of less than 50% or an increase of less than 25% of the sum of the products of perpendicular diameters of all measurable lesions or tumor marker CA125 with no development of new lesions for at least 4 weeks. Progressive disease (PD) Occurrence of new lesions; an increase of 25% or more in the sum of the areas of original measurement, or an elevated 25% of tumor marker CA125.

Outcome Time Frame:

4 weeks after completion of treatment

Safety Issue:


Principal Investigator

Chih-Ming Ho, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cathay General Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Ovarian Cancer
  • Adverse Effects
  • Sunitinib
  • recurrent ovarian cancer
  • clear cell carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma