Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Advanced Ovarian Cancer Clinical Trial

Official title:

Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462149
• Other study ID #: NEODOCA-OVCA
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2011
• Last updated: May 27, 2017
• Start date: October 2011
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Neoadjuvant chemotherapy
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
• Carboplatin
Carboplatin AUC 5, q 3 weeks, 3 cycles

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		1 month after completion of study treatment
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Before each chemotherapy, an average of 3 week
Secondary	Disease-free survival		2 years after completion of study treatment
Secondary	Overall survival		2 years after completion of study treatment
Secondary	The number of participants who achieved optimal cytoreduction		1 month after completion of study treatment