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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004095 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Breast Cancer Colorectal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors |
| Study Start Date: | August 1999 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:
Bidimensionally measurable disease outside a previously irradiated field
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Albert B. Benson, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004095 History of Changes |
| Other Study ID Numbers: | NU 98X3, NU-98X3, P-UPJOHN-976475157, NCI-G99-1588 |
| Study First Received: | December 10, 1999 |
| Last Updated: | January 28, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Urinary Bladder Neoplasms Breast Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Lung Neoplasms Pancreatic Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |