|
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Clinical research trials and Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer  Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
For Condition: recurrent ovarian epithelial cancer,stage 3 ovarian epithelial cancer,peritoneal cavity cancer,stage 4 ovarian epithelial cancer,Fallopian Tube Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing of die. PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer, primary fallopian tube cancer, or peritoneal cancer that has been previously treated with chemotherapy.
Details: OBJECTIVES: I. Compare the anti-tumor efficacy of two treatment schedules of lurtotecan liposome, in terms of clinical/radiological response and CA125 tumor marker, in patients with previously treated advanced or recurrent ovarian epithelial cancer. II. Compare the safety, pharmacokinetics, and possible pharmacokinetic/pharmacodynamic relationships of these treatment schedules in these patients. III. Compare the time to progression in patients treated with these treatment schedules. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to time from last prior chemotherapy (less than 6 months vs 6 months or more) and number of prior chemotherapy regimens (1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive lurtotecan liposome IV over 30 minutes on days 1-3. Arm II: Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documented CR. Patients achieving partial response (PR) receive 4 additional courses after documented PR or until disease progression at investigator's discretion. Patients with stable disease continue therapy for a maximum of 6 courses. Patients are followed at 4 weeks and then every 3 months until disease relapse or progression. PROJECTED ACCRUAL: A total of 40-74 patients (20-37 per treatment arm) will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed ovarian epithelial cancer; Primary fallopian or peritoneal cancer allowed - Clinically and/or radiologically documented advanced and/or recurrent disease - At least one site of disease unidimensionally measurable: Minimum indicator lesion site as follows: At least 10 mm on spiral CT scan; At least 20 mm on conventional CT scan; At least 20 mm on chest x-ray or physical exam; No recent prior radiotherapy to indicator lesion(s); Clear disease progression or new lesion within a previously irradiated field allowed - Previously treated with one or two chemotherapy regimens; At least one regimen must have contained cisplatin or carboplatin (changing from one prior platinum compound to another for disease progression or failure to respond is considered a second regimen); Use of same prior chemotherapy combination for first-line and second-line therapy is considered two regimens - No borderline ovarian tumor - No ascites as only disease presentation - No abdominal adenocarcinoma of unknown origin - No symptomatic brain metastasis that are potentially life-threatening or require active treatment --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered; No prior topotecan or other topoisomerase-I inhibitor; No other concurrent cytotoxic therapy for ovarian cancer - Endocrine therapy: No concurrent hormonal therapy for ovarian cancer - Radiotherapy: See Disease Characteristics; Recovered from prior radiotherapy; At least 4 weeks since prior radiotherapy to area comprising at least 25% of bone marrow stores - Surgery: At least 4 weeks since prior major surgery and recovered - Other: At least 30 days since prior investigational agent or new anticancer therapy; No other concurrent investigational therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); AST/ALT no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Other: No other prior malignancy within the past 5 years unless definitively treated with no evidence of recurrence; No known hypersensitivity to systemic liposomal formulations or drugs chemically related to study drug; No other serious illness or medical condition that would preclude study; No active uncontrolled infection; No complete bowel obstruction; No history of significant neurologic or psychiatric disorder that would preclude informed consent; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertGrimshaw, Study Chair, National Cancer Institute of Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
BCCC - Cancer Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0XO
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
City Hospital NHS Trust
Birmingham, England, B18 7QH
United Kingdom
Queen's University
Kingston, Ontario, K7L 3N6
Canada
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Additional Information:
Study ID Numbers: CDR0000068453; CAN-NCIC-110-06,CAN-NCIC-IND-138
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010179
Other Fallopian Tube Cancer Studies:
1. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
2. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
3. Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer
4. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
5. Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
Other Fallopian Tube Cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
|
|
|
|
|
|
|
|
