Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Sanofi
• Treatments: Carboplatin; Docetaxel

Criteria

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.