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OpenTrials
Completed

NCT Number: NCT00452985

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

15 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Sanofi-Aventis

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

60-75 mg/m²

carboplatin

Drug

AUC 5

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer

Acronym: OCSTUD

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2007
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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