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Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer (OCSTUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00452985
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary objective:

To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.

Secondary objective:

To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.


Condition or disease Intervention/treatment
Ovarian Neoplasms Drug: Docetaxel Drug: Carboplatin

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
Study Start Date : February 2002
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010


Group/Cohort Intervention/treatment
1
  • Injection of Docetaxel
  • 3-hour gap
  • Injection of carboplatin
Drug: Docetaxel
60-75 mg/m²

Drug: Carboplatin
AUC 5




Primary Outcome Measures :
  1. Measurements of the disease (assessed clinically and/or by CA-125) [ Time Frame: At baseline and from administration of drug to end of treatment ]
  2. Response rate [ Time Frame: From start to end of treatment ]
  3. Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status. [ Time Frame: From the beginning to the end of study ]
  4. Adverse events [ Time Frame: From the beginning to the end of the study ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: From administration of drug up to end of study ]
  2. Overall survival [ Time Frame: From administration of drug to end of study ]
  3. Biology and Hematology laboratory determinations [ Time Frame: From the beginning to the end of the study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced or metastatic ovarian cancer
Criteria

Inclusion Criteria:

  • Performance status Karnofsky index ≥ 60%.
  • Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan.
  • Histologically: epithelial/germ cell
  • Haematology: absolute neutrophil count: ≥2X10^9/L; Platelet: ≥150X10^9/L; Haemoglobin: ≥ 10g/dL
  • Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase & Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
  • Renal function: Creatinine: ≤130 µmol/L; If creatinine > 130 µmol/L, the 24 hour creatinine clearance should be > 60 ml/min.

Exclusion Criteria:

  • Symptomatic peripheral neuropathy > grade 1 by National Cancer Institute - Common Toxicity Criteria scale
  • Uncontrolled diabetes mellitus and uncontrolled hypertension
  • Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception).
  • Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT00452985


Locations
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Bangladesh
Sanofi-Aventis
Dhaka, Bangladesh
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Rezaul-Farid Khan, Dr Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00452985    
Other Study ID Numbers: TAX_BD1_601
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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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
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action