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Chemotherapy in Treating Patients With Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Chemotherapy in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Solid Tumors Clinical research trials and Chemotherapy in Treating Patients With Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Chemotherapy in Treating Patients With Solid Tumors. Chemotherapy in Treating Patients With Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy in Treating Patients With Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy in Treating Patients With Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Solid Tumors  Chemotherapy in Treating Patients With Solid Tumors
Chemotherapy in Treating Patients With Solid Tumors
For Condition: Head and Neck Cancer,Reproductive Cancers,Gastrointestinal Cancer,Kidney Cancer,Oral Cancer,Lung Cancer
Status: No longer recruiting
Sponsor(s): 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 augmerosen in treating patients who have solid tumors that have not responded to previous therapy.
Details: OBJECTIVES: I. Evaluate the safety and plasma concentration profiles of augmerosen (G3139) administered alone or in combination with docetaxel in patients with advanced solid tumors expressing the bcl-2 oncogene. II. Determine the plasma concentration profiles, maximum tolerated dose (MTD), and/or optimal biologic dose (OBD) of this treatment regimen in these patients. III. Determine the antitumor effects of G3139, at the MTD or OBD, in combination with docetaxel in patients with androgen independent, refractory, or recurrent prostate cancer. PROTOCOL OUTLINE: This is a dose-escalation study of augmerosen (G3139). Phase I: Patients receive G3139 IV on days 1-5 and docetaxel IV on day 5. Treatment repeats every 21 days for up to 6 courses of therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive G3139 continuously over 21 days at one dose level below the MTD in combination with weekly docetaxel. Patients receive up to 2 more courses of therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for phase I, and a total of 15 patients will be accrued for phase II, for a maximum accrual of 57 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Phase I: Histologically proven advanced, primary, or malignant solid tumors that are refractory to standard therapy or for which no curative therapy exists; Androgen independent prostate cancer; Head and neck cancers; Breast cancer; Non-small cell lung cancer; Colorectal cancer; Ovarian cancer; Esophageal cancer; Bladder cancer; Kidney cancer; Other solid tumors; Metastatic disease should not require palliative treatment within 4 weeks of enrollment - Phase II: Histologically proven androgen independent prostate cancer; Serum testosterone less than 30 ng/Ml Failed at least one prior chemotherapy regimen; Progressive; Minimum of 3 rising PSA values from baseline obtained at least 1 week apart OR Two rising PSA values more than one month apart AND At least 25% increase over range of values AND PSA at least 4 ng/Ml - No active CNS or epidural tumor - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: Concurrent medical therapy (i.e., gonadotropin releasing hormone analogs or diethylstilbestrol) to maintain castrate levels of serum testosterone allowed; No other concurrent hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; Concurrent radiotherapy to localized sites of disease not being evaluated in study allowed - Surgery: Not specified - Other: At least 4 weeks since prior investigational anticancer therapy and recovered; No concurrent intravenous antibiotics --Patient Characteristics-- - Age: 18 and over - Sex: Not specified - Menopausal status: Not specified - Performance status: Karnofsky 60-100% - Life expectancy: At least 6 months - Hematopoietic: WBC greater than 3500/mm3; Platelet count greater than 100,000/mm3; Prothrombin time less than 14 seconds - Hepatic: Bilirubin less than 2.0 mg/dL; SGOT less than 3 times the upper limit of normal - Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No New York Heart Association class III or IV cardiac disease - Pulmonary: No severe debilitating pulmonary disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active infection; No other severe medical problems
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMorris, 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: CDR0000065836; MSKCC-97096,NCI-G97-1337,GENTA-G3139-97/01
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003103
Other Head And Neck Cancer Studies:
1. High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
2. Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
3. Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
4. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
5. Alanosine in Treating Patients With Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy in Treating Patients With Solid Tumors
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