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.
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
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.
- First posted27 Jan 2003 (estimated)
- Study startDec 2001
- Primary completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter G. Rose, MD, Study chair, MetroHealth Cancer Care Center at MetroHealth Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT00030472
- Acronym / sponsor ID
- CDR0000069168
- Conditions
- Cervical Cancer
- Keywords
- recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2001
- Primary completion
- Oct 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Results publication: PubMed 16478630Rose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G. Rose, MD study chair
MetroHealth Cancer Care Center at MetroHealth Medical Center
17 sites in 2 countries: see every site and its status.
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.