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Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01462149
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Cancer Drug: Neoadjuvant chemotherapy Drug: Carboplatin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
Study Start Date : October 2011
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Response rate [ Time Frame: 1 month after completion of study treatment ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462149


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Sanofi
More Information

Responsible Party: Jong-Hyeok Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01462149     History of Changes
Other Study ID Numbers: NEODOCA-OVCA
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action