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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00964626
• Other study ID #: CDR0000641288
• Secondary ID: USSR-AMS-PAC-2EU
• Status: Recruiting
• Phase: Phase 2
• First received: August 22, 2009
• Last updated: August 23, 2013
• Start date: April 2009

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 72 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• cisplatin

• paclitaxel

Locations

Country	Name	City	State
Russian Federation	Russian Academy of Medical Sciences Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Objective response rate (complete and partial remission in patients with measurable disease)			No
Secondary	Toxicity			Yes