Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00003385|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: carboplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Official Title:||A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma|
|Study Start Date :||March 1999|
|Primary Completion Date :||January 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003385
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242-1009|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0587|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Study Chair:||Peter G. Rose, MD||MetroHealth Cancer Care Center at MetroHealth Medical Center|