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Ovarian CancerPhase 2NCT00964626

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

A Phase 2 study testing cisplatin and paclitaxel in people with Ovarian Cancer, run by Russian Academy of Medical Sciences at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 72 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
cisplatin and paclitaxel
How many people
60 participants
Where
1 siteRussia
Study dates
Apr 2009to Apr 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Russia1 site, 1 recruiting

  • Russian Academy of Medical Sciences Cancer Research Center

    Moscow, 115478

    Sergei A. Tjulandin, MD, PhD, 7-495-324-9874

    Recruiting

Other trials in Russia

About this study

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.

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
cisplatin, paclitaxel
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
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (3)

  1. Overall survival

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

  3. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964626
Sponsor's protocol ID
CDR0000641288
Other IDs
USSR-AMS-PAC-2, EU-20937, BIOCAD-PAC-2
Status last verified
Aug 2009
First submitted
22 Aug 2009
Last updated
26 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and paclitaxel in people with Ovarian Cancer, run by Russian Academy of Medical Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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