TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00539669
First received: October 3, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population.


Condition Intervention Phase
Ovarian Neoplasms
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.

Enrollment: 47
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 criteria).
  • 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 normal.
  • 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 contraception).
  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539669

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Hyang Rim Kim Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00539669     History of Changes
Other Study ID Numbers: XRP6976I_2502
Study First Received: October 3, 2007
Last Updated: October 3, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014