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SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer Clinical research trials and SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer. SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer  SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
For Condition: cervical squamous cell carcinoma,recurrent cervical cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.
Details: OBJECTIVES: I. Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma. II. Determine the nature and degree of toxicity of this drug in these patients. III. Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 8-23 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed cervical squamous cell carcinoma; Persistent or recurrent disease with documented progression; No nonsquamous cell cervical malignancies, including adenosquamous carcinoma - At least 1 measurable lesion; At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan - Failed prior local therapeutic measures - Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population) - Tumor must be accessible for biopsy using direct- or guided-needle technique --Prior/Concurrent Therapy-- - See Disease Characteristics - Biologic therapy: No prior antiangiogenesis agents, including SU5416; At least 3 weeks since prior biologic or immunologic agents directed at malignancy - Chemotherapy: No more than 1 prior chemotherapy regimen, including single or combination cytotoxic drug therapy (radiosensitizers do not count as prior regimen); At least 3 weeks since prior chemotherapy directed at malignancy and recovered - Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignancy; Concurrent hormone replacement therapy allowed - Radiotherapy: At least 3 weeks since prior radiotherapy directed at malignancy and recovered - Surgery: See Disease Characteristics; At least 3 weeks since prior surgery for malignancy and recovered - Other: No prior cancer therapy that would preclude study --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least lower limit of normal; Absolute neutrophil count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination; No myocardial infarction within the past 6 months; No severe/unstable angina within the past 6 months; No severe peripheral vascular disease; No deep vein or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: Not pregnant or nursing; Fertile patients must use effective contraception; Must have central venous access; No uncontrolled diabetes mellitus; No prior allergic reaction to paclitaxel; No active infection requiring antibiotics; No peripheral neuropathy greater than grade 1; No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin prophylaxis; No claustrophobia that would preclude MRI studies; No ferromagnetic implants or pacers; No other invasive malignancy within the past 5 years except non-melanoma skin cancer; No other concurrent circumstances that would preclude study completion
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertPark, Study Chair, Gynecologic Oncology Group
Additional Information:
Study ID Numbers: CDR0000069013; GOG-0227B
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026260
Other Cervical Squamous Cell Carcinoma Studies:
1. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
2. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
3. Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer
4. Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
5. Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
Related Studies:
Other cervical squamous cell carcinoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
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