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TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, 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 professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical research trials and TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer. TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer clinical trial. Human subjects often get the best healthcare possible for their TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer  TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,Fallopian Tube Cancer,ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as TLK286, liposomal doxorubicin, and topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether TLK286 is more effective than either liposomal doxorubicin or topotecan in treating metastaticovarian epithelial, fallopian tube, or primaryperitoneal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of TLK286 with that of either liposomal doxorubicin or topotecan as third-line therapy in treating patients who have platinum-refractory or platinum-resistant metastatic ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Details: OBJECTIVES: Primary - Compare survival of patients with platinum-refractory or -resistant metastatic ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with TLK286 vs active control therapy comprising doxorubicin HCl liposome or topotecan as third-line therapy. Secondary - Compare the safety profiles of these regimens in these patients. - Compare time to tumor progression in patients treated with these regimens. Tertiary - Compare the objective response rate (complete and partial response) in patients treated with these regimens. - Compare time to objective tumor response in patients treated with these regimens. - Compare duration of response in patients treated with these regimens. - Determine the pharmacokinetics of TLK286 in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior second-line therapy (doxorubicin vs topotecan), presence of bulky disease* (yes vs no), and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. NOTE: *Bulky disease is defined as the presence of a tumor mass at least 5 cm. - Arm I: Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. - Patients receive chemotherapy comprising 1 of the following regimens: - Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. - Patients receive topotecan IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 440 patients (220 per treatment arm) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer - The following histologies are eligible: - Serous papillary - Endometrioid - Mucinous - Clear cell - Poorly differentiated adenocarcinoma - Mixtures of the above - No sarcomatous, stromal, or germ cell cancers - Metastatic disease - Measurable disease - Pleural effusions, ascites, osseus metastases, CA125 tumor markers, and lesions in previously irradiated areas are not considered measurable - Platinum-refractory or -resistant* disease NOTE: *Platinum-resistant defined as disease recurrence within 6 months of completion of platinum-based chemotherapy OR recurrence after 6 months and failed re-induction with platinum-based chemotherapy - Failed 1, and only 1, second-line treatment with doxorubicin HCl liposome OR topotecan for advanced metastatic disease - Documented tumor progression within the past 3 months OR unresponsive to treatment - No known history of CNS metastasis except under the following conditions: - Treated with surgery or radiotherapy - Neurologically stable - No requirement for oral or IV corticosteroids or anticonvulsants - No leptomeningeal metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm^3 Hepatic - ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) - Alkaline phosphatase no greater than 5 times ULN (except when bone metastases are present without liver disorder) - Bilirubin no greater than 2 mg/dL (unless Gilbert's syndrome is clearly documented and other liver function tests are normal) Renal - Creatinine no greater than 2 mg/dL OR - Creatinine clearance at least 60 mL/min - No uncontrolled hypercalcemia (calcium at least 11.5 mg/dL) - No gross hematuria Cardiovascular - No New York Heart Association class II-IV cardiac disease - No unstable angina within the past 6 months - No symptomatic ventricular arrhythmias - No congestive heart failure - 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 6 months after study treatment - No intestinal obstruction that would interfere with nutrition - No history of uncontrolled seizures - No central nervous system disorders - No concurrent uncontrolled bacterial or viral infection - No psychiatric disorder that would preclude study compliance - No comorbidity that would preclude study participation - No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, incidental stage endometrial cancer, or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - More than 3 weeks since prior immunotherapy (e.g., interferon) and recovered - No prior bone marrow transplantation or stem cell support - Prior anticancer biologic investigational agents allowed - No concurrent biological response modifiers, except epoetin alfa Chemotherapy - See Disease Characteristics - More than 3 weeks since prior chemotherapy and recovered - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - More than 3 weeks since prior anticancer hormonal therapy, including anti-estrogens (e.g., tamoxifen) - No concurrent anticancer hormonal agents (e.g., tamoxifen) Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy or radiopharmaceuticals (e.g., phosphorus P32) and recovered - More than 12 months since prior whole pelvis radiotherapy - No concurrent radiotherapy except for brain metastases or bone metastases pain control - Radiotherapy field must not encompass exposure to the bladder Surgery - See Disease Characteristics - More than 3 weeks since prior major surgery (except for minor biopsy or venous access device placement) and recovered Other - More than 2 weeks since prior blood transfusion - More than 3 weeks since prior investigational drugs - No prior investigational cytotoxic drugs - Prior cytostatic investigational agents allowed - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSpriggs, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Spriggs 212-639-2203
Additional Information:
Study ID Numbers: CDR0000353149; TLK-286.3017,MSKCC-03087
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078884
Other Ovarian Epithelial Cancer Studies:
1. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
2. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
3. Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
4. Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other ovarian epithelial cancer Clinical Trials
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TLK286 Compared With Either Liposomal Doxorubicin or Topotecan as Third-Line Therapy in Treating Patients With Platinum-Refractory or Platinum-Resistant Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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