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TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical research trials and TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer  TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
For Condition: ovarian mixed epithelial carcinoma,ovarian clear cell cystadenocarcinoma,ovarian serous cystadenocarcinoma,Fallopian Tube Cancer,stage 4 ovarian epithelial cancer,ovarian mucinous cystadenocarcinoma,recurrent ovarian epithelial cancer,ovarian undifferentiated adenocarcinoma,ovarian endometrioid adenocarcinoma,peritoneal cavity cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
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 of TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen in these patients. III. Determine the duration of objective response, time to tumor progression, and overall survival in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer; Serous papillary; Endometrioid; Mucinous; Clear cell; Poorly differentiated adenocarcinomas; Mixture of any of the above histologies - No sarcomatous, stromal, or germ cell elements - Measurable disease by radiological imaging with progression in the past 3 months or no response to prior therapy; The following are not considered measurable: Pleural effusions; Ascites Osseous metastases; CA-125 tumor markers; Lesions in previously irradiated areas - Platinum resistant or refractory; Less than 6 month treatment-free interval after platinum-containing regimen OR Progression during platinum-based therapy - No leptomeningeal or carcinomatous meningitis - Known CNS metastases allowed if patient is previously treated, neurologically stable, has no evidence of active disease by CT or MRI, and has no requirement for therapy with oral or IV steroids or anticonvulsants --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy and recovered; At least 2 weeks since prior prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent immunotherapy; No concurrent biological response modifiers - Chemotherapy: See Disease Characteristics; At least 1 but no more than 3 prior chemotherapy regimens (platinum-containing regimens count as 1 regimen); At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics - Radiotherapy: At least 4 weeks since prior radiotherapy or radiopharmaceuticals and recovered; No prior radiotherapy to whole pelvis; No concurrent radiotherapy including palliative radiotherapy (except local radiotherapy for pain or solitary brain metastasis if not progressing systemically) - Surgery: At least 4 weeks since prior major surgery and recovered - Other: At least 30 days since prior investigational drugs; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 2.5 mg/dL; ALT and AST no greater than 3.0 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; No gross hematuria - Cardiovascular: No uncontrolled cardiac arrhythmia; No myocardial infarction within the past 6 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 6 months after study; No unstable medical conditions; No severe concurrent disease or infection that would preclude study; No intestinal obstruction interfering with nutrition; No psychiatric disorders that would preclude study; No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSpriggs, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068807; MSKCC-01059,TLK-286.2003,NCI-G01-1998
Study Start Date: May 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022347
Other Ovarian Clear Cell Cystadenocarcinoma Studies:
1. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
3. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
4. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
Related Studies:
Other ovarian clear cell cystadenocarcinoma Clinical Trials
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TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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