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Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 22, 2009
Last updated: August 23, 2013
Last verified: August 2009

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

Condition Intervention Phase
Ovarian Cancer
Drug: cisplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV.

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival

Secondary Outcome Measures:
  • Overall survival
  • Objective response rate (complete and partial remission in patients with measurable disease)
  • Toxicity

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.


Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary

    • Stage IC-IV disease
  • No known or clinical evidence of brain metastasis


  • ECOG performance status 0-2
  • Hemoglobin must be ≥ 90 g/L
  • ANC ≥ 2 x 10^9/L
  • Platelet count ≥ 100 x10^9/L
  • Serum creatinine ≤ 115 μmol/L
  • Total bilirubin ≤ 25 μmol/L
  • Not pregnant or nursing
  • No other serious disease which could affect protocol compliance and results
  • No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin
  • No peripheral neuropathy ≥ CTCAE version 3.0 grade 2
  • No known hypersensitivity to any of the study drugs or their excipients
  • No drug addiction or alcoholism
  • No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements


  • No prior chemotherapy or radiotherapy for ovarian cancer
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Please refer to this study by its identifier: NCT00964626

Russian Federation
Russian Academy of Medical Sciences Cancer Research Center Recruiting
Moscow, Russian Federation, 115478
Contact: Sergei A. Tjulandin, MD, PhD    7-495-324-9874      
Sponsors and Collaborators
Russian Academy of Medical Sciences
Principal Investigator: Sergei A. Tjulandin, MD, PhD Russian Academy of Medical Sciences
  More Information Identifier: NCT00964626     History of Changes
Other Study ID Numbers: CDR0000641288
Study First Received: August 22, 2009
Last Updated: August 23, 2013

Keywords provided by National Cancer Institute (NCI):
stage IA ovarian epithelial cancer
stage IB ovarian epithelial cancer
stage IC ovarian epithelial cancer
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
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
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017