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Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma Clinical research trials and Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma. Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma  Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
For Condition: stage 4B adult soft tissue sarcoma,recurrent adult soft tissue sarcoma,stage 4 adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive 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 irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy.
Details: OBJECTIVES: I. Evaluate the efficacy of irinotecan in patients with metastatic, recurrent, or unresectable locally advanced previously treated soft tissue sarcoma. II. Assess the clinical and laboratory toxic effects and patient tolerance of this regimen in these patients. PROTOCOL OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks, followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for the first two years, then every 6 months for the next two years, and every 12 months thereafter until death. PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study in 18-36 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 recurrent or stage IV (metastatic or locally advanced) unresectable soft tissue sarcoma; Patients with soft tissue; Ewing's sarcoma, Kaposi's sarcoma, sarcoma of the bone, and mesothelioma are not eligible; Must have failed at least one, but no more than two, prior chemotherapy regimens, one of which contained doxorubicin either as adjuvant therapy or first-line therapy for metastatic disease - Bidimensionally measurable disease on x-ray, MRI or CT scan, or physical exam (outside of previously irradiated area) - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic response modifier therapy allowed - Chemotherapy: See Disease Characteristics; No prior irinotecan or topotecan; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: At least 4 weeks since prior surgery and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least lower limit of normal; WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,750/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN with liver tumor involvement) - Renal: Creatinine less than ULN OR Creatinine clearance greater than 60 mL/min; Calcium less than ULN - Cardiovascular: No myocardial infarction within past 6 months; No congestive heart failure requiring therapy - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No physical, mental, or emotional disorders; No other prior malignancy within the past 5 years, except: Adequately treated basal or squamous cell skin cancer; Carcinoma in situ of the cervix; Adequately treated stage I or II cancer in complete remission; No active or uncontrolled infection; HIV negative; No known Gilbert's syndrome; No uncontrolled diabetes (random blood sugar at least 200 mg)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertTaub, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000066828; CPMC-IRB-8100,NCI-V98-1511
Study Start Date: July 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003719
Other Stage 4 Adult Soft Tissue Sarcoma Studies:
1. Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
2. Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
4. Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
5. Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
Related Studies:
Other stage 4 adult soft tissue sarcoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
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