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Home > "G" Clinical Trials Conditions > Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary  Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
For Condition: newly diagnosed carcinoma of unknown primary,undifferentiated carcinoma of unknown primary,adenocarcinoma of unknown primary,squamous cell carcinoma of unknown primary
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan 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 combining gemcitabine with irinotecan in treating patients who have cancer of unknown primary origin.
Details: OBJECTIVES: Primary - Determine the response rate in patients with carcinoma of unknown primary when treated with gemcitabine and irinotecan. - Determine the adverse event profile and tolerability of this regimen, based on the presence or absence of the UGT1A1*28 polymorphism, in these patients. (Cohort I) - Determine the adverse event profile and tolerability of this regimen, when dosed according to the relationship between toxicity and UGT1A1 genotype found in cohort I, in these patients. (Cohort II) Secondary - Determine the time to progression and overall survival of patients treated with this regimen. - Correlate patterns of immunohistochemical staining with response in patients treated with this regimen. - Correlate variation in multiple different genes, whose protein products are involved in the uptake, metabolism, and distribution of these drugs, with clinical outcomes, in terms of response and toxicity, in these patients. OUTLINE: - Cohort I: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. - Cohort II: Patients receive treatment as in cohort I at a dose determined by the relationship of the UGT1A1*28 polymorphism and toxicity in cohort I. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 42-54 patients (6 patients with the UGT1A1*28 polymorphism and 6 patients without the UGT1A1*28 polymorphism for cohort I and 30-42 for cohort II) will be accrued for this study within approximately 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed carcinoma of undetermined origin, with any of the following light microscopic diagnoses: - Adenocarcinoma - Poorly differentiated non-small cell carcinoma - Poorly differentiated squamous cell carcinoma - Primary site not revealed by the following diagnostic tests: - Complete history and physical - Complete blood count and chemistries - Chest x-ray and/or CT scan - Abdominal CT scan - Directed evaluation of symptomatic areas - Mammogram in women - Colonoscopy in patients with liver metastases to exclude a colon primary - Measurable disease - Must have undergone UGT1A1 genotyping - Patients with any of the following conditions are not eligible: - Neuroendocrine tumors - Women with axillary node involvement only - Women with adenocarcinoma of the peritoneum - Carcinoma involving only 1 site, with resectable tumor at that site - Squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes - Men with poorly differentiated mediastinal or retroperitoneal tumor with stains suggestive of germ cell origin or serum tumor markers (AFP/HCG) - Men with prominent blastic bony metastases or markedly elevated prostate-specific antigen, suggesting prostate origin - No brain or meningeal involvement PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN - AST no greater than 3 times ULN (5 times ULN if liver metastases are present) - No known Gilbert's syndrome Renal - Creatinine no greater than 2.0 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other invasive malignancy within the past 5 years - No other severe concurrent disease that would make the patient inappropriate for the study in the judgment of the investigator - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic agents - No concurrent filgrastim (G-CSF) Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to more than 25% of the bone marrow - No concurrent radiotherapy Surgery - More than 4 weeks since prior major surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MatthewAmes, , Mayo Clinic Cancer Center
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
Additional Information:
Study ID Numbers: CDR0000318830; NCCTG-N004E
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066781
Other Undifferentiated Carcinoma Of Unknown Primary Studies:
1. Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
2. Combination Chemotherapy in Treating Patients With Metastatic Cancer of an Unknown Site of Origin
Related Studies:
Other undifferentiated carcinoma of unknown primary Clinical Trials
Other North Dakota Clinical Trials
Other Grand Forks Clinical Trials
Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
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