NCT00964626

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

August 22, 2009

Last Update Submit

August 23, 2013

Conditions

Ovarian Cancer

Keywords

stage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (3)

  • Overall survival

  • Objective response rate (complete and partial remission in patients with measurable disease)

  • Toxicity

Interventions

cisplatinDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years - 72 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CisplatinPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Sergei A. Tjulandin, MD, PhD

    Russian Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2009

First Posted

August 25, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Last Updated

August 26, 2013

Record last verified: 2009-08

Locations

RU(1)