Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
Carcinoma of Unknown Primary
About this trial
This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary, squamous cell carcinoma of unknown primary, undifferentiated carcinoma of unknown primary
Eligibility 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 Hematoxylin and eosin (H&E) staining OR immunostaining if H&E results are unclear, including all of the following: Keratin or epithelial membrane antigen S-100 or HMB45 LCA (CD45) Chromogranin or synaptophysin Thyroid transcription factor 1 Measurable disease 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 Must be willing to provide blood and tissue samples 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 must meet 1 of the following criteria: Less than or equal to upper limit of normal (ULN) and no UGT1A1 genotyping is required Greater than ULN but less than 2 times ULN and UGT1A1 for 6/7 genotype or 7/7 genotype patients Alkaline phosphatase no greater than 3 times ULN AST no greater than 3 times ULN (5 times ULN if liver metastases are present) 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
Sites / Locations
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Mayo Clinic Cancer Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort I (closed to accrual 11/17/05)
Cohort II
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.
Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.