Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
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 I trial to study the effectiveness of combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors.
Checked against the public recordLast updated Apr 18, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Northwestern University
- Interventions being studied
- Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease: * Bladder cancer - no more than 1 prior therapy * Breast cancer - no more than 2 prior therapies * Colorectal cancer - no more than 1 prior therapy * Kidney cancer - no prior therapy * Lung cancer - no more than 1 prior therapy * Pancreatic cancer - no prior therapy * Bidimensionally measurable disease outside a previously irradiated field * At least 2 cm x 2 cm * No known bone metastases * CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor * SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) * No known Gilbert's disease Renal: * Creatinine no greater than 1.8 mg/dL * Calcium less than 12.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy Other: * No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection * No psychiatric disorders that would prevent compliance * No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No history of seizures * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent sargramostim (GM-CSF) * No concurrent immunotherapy Chemotherapy: * No prior irinotecan, topotecan, or gemcitabine * Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy to less than 30% of bone marrow * No prior whole pelvic radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 18, 2017. Always confirm current availability with the study team.