Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

May 27, 2017 updated by: Jong-Hyeok Kim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy
Neoadjuvant chemotherapy with docetaxel plus carboplatin
Drug: Neoadjuvant chemotherapy
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
Drug: Carboplatin
Carboplatin AUC 5, q 3 weeks, 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 1 month after completion of study treatment
1 month after completion of study treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 31, 2011

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEODOCA-OVCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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