Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01462149

Enrollment

Registered

2011-10-31

Start date

2011-10-31

Completion date

2016-06-30

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Ovarian Cancer

Brief 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.

Interventions

DRUGNeoadjuvant chemotherapy

Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles

DRUGCarboplatin

Carboplatin AUC 5, q 3 weeks, 3 cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Response rate	1 month after completion of study treatment

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026