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Cervical CancerPhase 2NCT00030472

Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 17 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cervical Cancer
What is being tested?
pegylated liposomal doxorubicin hydrochloride
How many people
Not given
Where
17 sitesin 2 countries
Study dates
Dec 2001to Oct 2006
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma (SCC) of the cervix
  • Persistent or recurrent progressive disease
  • Must have failed local therapeutic measures and considered incurable
  • 1 prior chemotherapeutic regimen for SCC of the cervix required
  • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • Ineligible for a higher priority GOG protocol
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • Target lesion may not be within a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 100,000/mm3
  • Absolute neutrophil count at least 1,500/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No congestive heart failure
  • No unstable angina
  • No myocardial infarction or new cardiac arrhythmia in the past 6 months

Other:

  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management)
  • At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix

Chemotherapy:

  • See Disease Characteristics
  • No prior doxorubicin or doxorubicin HCl liposome
  • 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management)
  • No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • Recovered from prior chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for SCC of the cervix
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery:

  • Recovered from prior surgery

Other:

  • At least 3 weeks since other prior therapy for SCC of the cervix
  • No prior anticancer treatment that precludes study

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States16 sites
  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0526

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas M.D. Anderson CCOP Research Base

    Houston, Texas, 77030-4009

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1740

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11794-8091

Other trials in United States

Norway1 site
  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

Conditions
Cervical Cancer
Being tested
pegylated liposomal doxorubicin hydrochloride
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • pegylated liposomal doxorubicin hydrochlorideDrug

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2001
  3. Primary completionOct 2006

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030472
Sponsor's protocol ID
CDR0000069168
Other IDs
GOG-0127R
Status last verified
Sep 2004
First submitted
14 Feb 2002
Last updated
11 Apr 2013
Results posted
No

Publications

  • Rose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. doi: 10.1016/j.ygyno.2005.11.048. Epub 2006 Feb 14.

    PubMed 16478630

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 17 sites in 2 countries.

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

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Norway. 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?

The study was stopped early. Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030472, which also lists 1 linked publication.

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 11 Apr 2013.

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