Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Advanced Ovarian Cancer

Treatments

Drug: Neoadjuvant chemotherapy

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01462149

NEODOCA-OVCA

Details and patient eligibility

About

Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.

Enrollment

43 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced epithelial, tubal, or primary peritoneal cancer
Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
Less probability of complete cytoreduction
Age: 20-80 years
GOG performance status: 0-3
Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3

Exclusion criteria

Previous chemotherapy or pelvic radiation therapy
Final diagnosis is other malignancies
Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
History of severe allergy
Pregnancy, lactating woman
Uncontrolled medial disease
Bowel obstruction requiring immediate surgery
Etc.