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Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors Clinical research trials and Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors  Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
For Condition: recurrent testicular cancer,stage 4 ovarian germ cell tumor,stage 3 testicular cancer,recurrent ovarian germ cell tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.
Details: OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the toxic effects of this regimen in these patients. PROTOCOL OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter. PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or serologically confirmed metastatic germ cell neoplasm (gonadal or extragonadal primary) that cannot be cured with either surgery or chemotherapy; Seminomas, nonseminomas, or ovarian germ cell tumors allowed - If histologically confirmed, requires one or more of the following: Metastatic lesions on chest x-ray or CT scan; Rising serum HCG or AFP; If only evidence of progressive disease, then two additional consecutive determinations must exhibit serologic progression; Only eligible if alternative causes for increased serum levels are absent - Failed initial cisplatin combination chemotherapy (generally bleomycin/etoposide/cisplatin, cisplatin/etoposide, cisplatin/vinblastine, or similar regimens) - Failed and demonstrated progressive disease following the administration of at least one "salvage" regimen for advanced germ cell neoplasms - Failed no more than three prior regimens defined as: 25% increase in the product of perpendicular diameters of measurable tumor masses during prior therapy, new lesions OR Increasing AFP or HCG - Disease progression during initial induction chemotherapy or with primary mediastinal nonseminomatous germ cell tumors can be treated with paclitaxel plus gemcitabine as second-line therapy (initial salvage chemotherapy) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered - Surgery: At least 3 weeks since major surgery and recovered - Other: At least 1 week since prior intravenous antibiotics; No concurrent intravenous antibiotics --Patient Characteristics-- - Age: 15 and over - Performance status: ECOG 0-2 - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT no greater than 4 times normal; Bilirubin no greater than 2 mg/dL - Renal: Creatinine no greater than 2.5 mg/dL - Other: No active uncontrolled infection; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceEinhorn, Study Chair, Eastern Cooperative Oncology Group
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Pretoria Academic Hospital
Pretoria, , 0001
South Africa
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Additional Information:
Study ID Numbers: CDR0000066562; E-9897
Study Start Date: January 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003518
Other Recurrent Ovarian Germ Cell Tumor Studies:
1. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
2. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
3. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
Related Studies:
Other recurrent ovarian germ cell tumor Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
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