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Phase 2
18 Years
Not Enrolling
Ovarian Neoplasms

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Trial Information

Inclusion Criteria:

- Histologically confirmed epithelial ovarian carcinoma. Patients with peritoneal
carcinomatosis are also eligible, without necessarily having histological proof of a
primary source in the ovary, provided that the tumour is not mucin-secreting, and
that there is no evidence of a primary fallopian tube cancer (see exclusion

- Female, aged 18 or over- FIGO stages Ic-IV with or without successful cytoreductive
surgery at staging laparotomy. Stage Ic patients will be limited to those with
malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface
of the ovary

- Patients with ruptured capsule as the only evidence of stage Ic will not be eligible
for entry into the study.

Exclusion Criteria:

- ECOG performance status > 2

- Prior treatment with chemotherapy or radiotherapy.

- Patients with, pre-existing fluid retention such as pleural effusion, pericardial
effusion and ascites are not excluded from the study, but should be monitored closely
for any deterioration. Efforts should be made to determine by cytological analysis
whether any significant pre-existing fluid collections are due to ovarian cancer, and
subsequent drainage is recommended before initiating chemotherapy.

- Inadequate bone marrow function defined as neutrophils < 1.5 x 109/l or platelets <
100 x 109/l.

- Inadequate renal function as defined by serum creatinine > 1.25 x upper limit of

- Inadequate liver function as defined by bilirubin > upper limit of normal or AST/ALT
> 1.5 x upper limit of normal or ALP > 3 x upper limit of normal.

- Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled
infection, hypertension, ischaemic heart disease, myocardial infarction within
previous 6 months, congestive heart failure)

- Patients with mixed mesodermal tumours.

- Patients with borderline ovarian tumours or tumours termed 'possibly malignant'.

- Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting
cancer or thought to be possible primary fallopian tube carcinoma.

- History of previous malignancy within the previous 5 years (except curatively treated
carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or
concurrent malignancy (e.g. coexisting endometrial cancer) .

- History of prior serious allergic reactions (e.g. anaphylactic shock).

- History of other relative contraindications to corticosteroid administration

- Pregnant or lactating women (or potentially fertile women not using adequate

- Symptomatic peripheral neuropathy > NCIC-CTC grade II.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated.

Principal Investigator

Hyang Rim Kim

Investigator Role:

Study Director

Investigator Affiliation:



Korea: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms