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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964626
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 25, 2009
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: cisplatin Drug: paclitaxel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (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.
Study Start Date : April 2009
Estimated Primary Completion Date : April 2011

Primary Outcome Measures :
  1. Progression-free survival

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00964626     History of Changes
Other Study ID Numbers: CDR0000641288
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2009

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