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Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical research trials and Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix. Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix clinical trial. Participants frequently get the best healthcare available for their Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix  Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
For Condition: recurrent cervical cancer,cervical squamous cell carcinoma,stage 4B cervical cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, MetroHealth Medical Center
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1740
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0526
United States
Additional Information:
Study ID Numbers: CDR0000069168; GOG-0127R
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030472
Other Stage 4b Cervical Cancer Studies:
1. PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
2. Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
3. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
4. Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
5. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Related Studies:
Other stage 4B cervical cancer Clinical Trials
Other California Clinical Trials
Other Los Gatos Clinical Trials
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
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