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TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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 allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer clinical trial. Human subjects often get the best 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, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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 Stage 4 Ovarian Epithelial Cancer Studies:
1. Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
2. Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
3. Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
5. Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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