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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.


Phase 2
18 Years
72 Years
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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.


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Sergei A. Tjulandin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Russian Academy of Medical Sciences Cancer Research Center

Authority:

Unspecified

Study ID:

CDR0000641288

NCT ID:

NCT00964626

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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