Know Cancer

or
forgot password

The Evaluation of Efficacy and Safety of Subsequent Cisplatin and Docetaxel Regimen In The First Line Treatment of Advanced Epithelial Ovarian Cancer


Phase 2
18 Years
70 Years
Not Enrolling
Female
Ovarian Neoplasms

Thank you

Trial Information

The Evaluation of Efficacy and Safety of Subsequent Cisplatin and Docetaxel Regimen In The First Line Treatment of Advanced Epithelial Ovarian Cancer


Inclusion Criteria:



- Histologically/cytologically confirmed, optimally debulked stage III-IV epithelial
ovarian cancer excluding clear cell histology.

- ECOG Performance Status is 0-2

- No prior chemotherapy for this malignancy,

- Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a
platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as
defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance by formulation ≥ 60
mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value
even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value;
alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone
metastasis)

Exclusion Criteria:

- Concomitant use of another anti-cancer therapy

- Unstable medical condition that makes the patient unable to take part in a clinical
study (congestive heart failure, serious arrythmia, uncontrolled diabetes mellitus),
history of myocardial infarction within last 3 months, massive pleural, peritoneal or
pericardial effusion; or presence of serious uncontrolled infection.

- Presence of other tumours different from basal cell carcinoma of the skin.

- Pregnancy or breastfeeding. In women of childbearing potential and in men, an
adequate contraceptive method must be used

- Social or psychological condition that render the patient inadequate for the
follow-up of the study

- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any
of the ingredients of the study drugs)

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy by response rate according to RECIST criteria and safety

Outcome Time Frame:

After the 2nd cycle, 4th cycle and 8th cycle and at the follow up period

Safety Issue:

No

Principal Investigator

Edibe Taylan, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Turkey: Ministry of Health

Study ID:

XRP6976I_6012

NCT ID:

NCT00772863

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location