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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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
cisplatin
paclitaxel
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring 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

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Russian Academy of Medical Sciences Cancer Research CenterRecruiting

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Objective response rate (complete and partial remission in patients with measurable disease)
Toxicity

Full Information

First Posted
August 22, 2009
Last Updated
August 23, 2013
Sponsor
Russian Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00964626
Brief Title
Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Russian Academy of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Objective response rate (complete and partial remission in patients with measurable disease)
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei A. Tjulandin, MD, PhD
Organizational Affiliation
Russian Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergei A. Tjulandin, MD, PhD
Phone
7-495-324-9874

12. IPD Sharing Statement

Learn more about this trial

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

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