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Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors

Primary Purpose

Bladder Cancer, Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
irinotecan hydrochloride
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irinotecan Plus Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
April 14, 2017
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004095
Brief Title
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Official Title
Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan and gemcitabine in patients with surgically unresectable or metastatic solid tumors. Determine if the principal toxicities and MTD of this combination regimen are affected by drug sequencing in this patient population. Determine the potential for gemcitabine to alter the pharmacokinetic characteristics when administered with irinotecan in these patients. Describe the influence effected by varying the administration sequence of this combination regimen in this patient population. Obtain preliminary data regarding efficacy of this combination regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive subsequent doses of the inverse sequence of the combination drugs until a new MTD is determined. Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months until death. PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer
Keywords
stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan Plus Gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al B. Benson, MD, FACP
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Wisinski KB, Mulcahy MF, Newman S, et al.: A phase I study of irinotecan and gemcitabine in solid tumors. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-140, 2007.
Results Reference
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Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors

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