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Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma

NCT01824615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-07-18

No results posted yet for this study

Summary

Patients with early and advanced stages of epithelial ovarian cancer are treated with postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive surgery. For ovarian cancer patients with recurrence, salvage chemotherapy with or without secondary cytoreductive surgery are recommended. The recommendation for specific primary adjuvant or salvage chemotherapy is cyclophosphamide or paclitaxel plus platinum regimens. Despite the high objective response rate associated with primary chemotherapy in ovarian cancer, the majority of patients will eventually experience disease recurrence and be potential candidates for a second-line treatment approach.

Ovarian clear cell adenocarcinoma (OCCA) is recognized as a distinct histological type of cancer in the WHO-classification of ovarian tumors. OCCA is thought to arise from endometriosis and most patients present with the disease at early stages (International Federation of Gynecology and Obstetrics (FIGO) stages I and II). The incidence of OCCA among epithelial ovarian cancers is estimated to be less than 5-10%. However, OCCA occurs more frequent in Japan and Taiwan (around 10-15%). Unfortunately, OCCA is usually more resistant to systemic chemotherapy than other types and has a poorer prognosis.

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. Due to its multi-targeted profile, the pharmacological activity of sunitinib is likely mediated by inhibition of multiple RTK targets and multiple pathways. c-KIT has been implicated in mastocytosis/mast cell leukemia, germ cell cancers, small-cell lung cancer, GISTs, AML, neuroblastoma, melanoma, and ovarian and breast carcinoma. In addition, sunitinib has demonstrated a higher response rate than that reported for anti- VEGF antibody treatment in patients with renal cell carcinoma (RCC). A few clinical case reports indicated sunitinib is effective in treating recurrent ovarian clear cell adenocarcinoma (OCCA) which is almost resistant to second line chemotherapy.

So we would like to conduct this Phase II Sunitinib clinical trial in recurrent / persistent ovarian clear cell cancer patients.

Conditions

Interventions

DRUG

Sunitinib

37.5mg everyday from D1-D28

Sponsors & Collaborators

  • Cathay General Hospital

    lead OTHER

Principal Investigators

  • Chih-Ming Ho, Ph.D. · Cathay General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824615 on ClinicalTrials.gov