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


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 22, 2009)
Progression-free survival [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00964626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 22, 2009)
  • Overall survival [ Designated as safety issue: No ]
  • Objective response rate (complete and partial remission in patients with measurable disease) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEPaclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
Official Title  ICMJEA 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.
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.

Detailed Description

OBJECTIVES:

  • 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 PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Open Label
Condition  ICMJEOvarian Cancer
Intervention  ICMJE
  • Drug: cisplatin
  • Drug: paclitaxel

Recruitment Information

Estimated Enrollment  ICMJE60
Completion Date 
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for ovarian cancer
GenderFemale
Ages18 Years to 72 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00964626
Responsible Party 
Study ID Numbers  ICMJECDR0000641288, USSR-AMS-PAC-2, EU-20937, BIOCAD-PAC-2
Study Sponsor  ICMJERussian Academy of Medical Sciences Cancer Research Center
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Sergei A. Tjulandin, MD, PhDRussian Academy of Medical Sciences Cancer Research Center
Information Provided ByNational Cancer Institute (NCI)