Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
This study has been completed.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003368
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Phase I

MedlinePlus related topics: Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Irinotecan Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Irinotecan for Patients With Abnormal Liver or Renal Function or With Prior Pelvic Radiation Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1998
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in patients with solid tumors or lymphoma who have liver or renal dysfunction or have had prior pelvic radiation. II. Characterize the pharmacokinetics of irinotecan in these patients.

OUTLINE: This is a dose escalation study. Patients are stratified according to prior pelvic radiation therapy (yes vs no). Patients with no prior pelvic radiation are further stratified according to AST, bilirubin, and creatinine levels. Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses. After patients are reevaluated, treatment may continue in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of irinotecan. Dose escalation proceeds within each stratum until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven solid tumors or lymphoma refractory to standard therapy or for which no standard therapy exists Brain metastases allowed if following criteria met: Asymptomatic Received prior therapy for brain metastases Stable for at least 2 months No concurrent steroid therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic and Renal: Albumin at least 2.5 g/dL Prothrombin time less than 1.6 For patients without prior pelvic radiotherapy: AST at least 3 times upper limit of normal (ULN) OR Bilirubin 1.0 - 7.0 mg/dL with any AST OR Creatinine 1.6 - 5.0 mg/dL For patients with prior pelvic radiotherapy: AST less than 3 times ULN AND Bilirubin less than 1.0 mg/dL AND Creatinine less than 1.6 mg/dL Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since melphalan or mitomycin) At least 3 months since suramin No prior nitrosoureas or irinotecan Endocrine therapy: No concurrent steroids (except as antiemetic for chemotherapy) Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since major surgery Other: No concurrent medications known to affect hepatic or renal function (e.g., antiseizure medication or nonsteroidal antiinflammatory drugs)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003368

  Show 45 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Alan P. Venook, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000066357, CLB-9863
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003368  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:
Sezary syndrome
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Ileal Diseases
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Camptothecin
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Irinotecan
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Jejunal Diseases
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009