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Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer  Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
For Condition: ovarian epithelial cancer,Fallopian Tube Cancer,peritoneal cavity cancer
Status: No longer recruiting
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial, peritoneal, or fallopian tube cancer. - Determine the toxicity of this treatment regimen in these patients. - Evaluate measurable disease in patients treated with this regimen. OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox). Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma - The following histologic epithelial cell types are eligible: - Serous adenocarcinoma - Endometrioid adenocarcinoma - Mucinous adenocarcinoma - Undifferentiated carcinoma - Clear cell adenocarcinoma - Mixed epithelial carcinoma - Transitional cell - Malignant Brenner tumor - Adenocarcinoma not otherwise specified - No more than 12 weeks since diagnosis - No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT/SGPT no greater than 3 times normal - Alkaline phosphatase no greater than 3 times normal - Gamma-glutamyl-transferase no greater than 3 times normal - No acute hepatitis Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance greater than 50 mL/min Cardiovascular: - LVEF normal by MUGA - No unstable angina - No myocardial infarction within the past 6 months - Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months Other: - No septicemia or severe infection - No severe gastrointestinal bleeding - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Recovered from recent prior surgery Other: - No prior anticancer therapy that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, MetroHealth Medical Center
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000066381; GOG-9703
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003385
Other Fallopian Tube Cancer Studies:
1. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
2. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
3. Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
4. Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
5. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
Related Studies:
Other Fallopian Tube Cancer Clinical Trials
Other Ohio Clinical Trials
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Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
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