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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

NCT ID: NCT00964626

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cisplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Sergei A. Tjulandin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Russian Academy of Medical Sciences

Locations

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Russian Academy of Medical Sciences Cancer Research Center

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Sergei A. Tjulandin, MD, PhD

Role: primary

Other Identifiers

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USSR-AMS-PAC-2

Identifier Type: -

Identifier Source: secondary_id

EU-20937

Identifier Type: -

Identifier Source: secondary_id

BIOCAD-PAC-2

Identifier Type: -

Identifier Source: secondary_id

CDR0000641288

Identifier Type: -

Identifier Source: org_study_id