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Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

This study is currently recruiting participants.
Verified October 2011 by Asan Medical Center
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Jong-Hyeok Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01462149
First received: October 25, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Ovarian Cancer
 Drug: Neoadjuvant chemotherapy
Drug: Carboplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 1 month after completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Before each chemotherapy, an average of 3 week ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: 2 years after completion of study treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years after completion of study treatment ] [ Designated as safety issue: No ]
  • The number of participants who achieved optimal cytoreduction [ Time Frame: 1 month after completion of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462149

Contacts
Contact: Jong-Hyeok Kim, M.D., Ph.D. +82-2-3010-3643 hyeokkim@amc.seoul.kr
Contact: Jeong-Yeol Park, M.D., Ph.D. +82-2-3010-3646 obgyjypark@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jong-Hyeok Kim, M.D., Ph.D.     +82-2-3010-3643     hyeokkim@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
Sanofi
  More Information

No publications provided

Responsible Party: Jong-Hyeok Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01462149     History of Changes
Other Study ID Numbers: NEODOCA-OVCA
Study First Received: October 25, 2011
Last Updated: October 27, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013