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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004095
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : April 18, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Breast Cancer Colorectal Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
Study Start Date : August 1999
Primary Completion Date : October 2008
Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: Irinotecan Plus Gemcitabine Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.8 mg/dL
  • Calcium less than 12.0 mg/dL


  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring therapy


  • 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


Biologic therapy:

  • No concurrent sargramostim (GM-CSF)
  • No concurrent immunotherapy


  • 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


  • 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


  • See Disease Characteristics


  • No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004095

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Al B. Benson, MD, FACP Robert H. Lurie Cancer Center

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.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004095     History of Changes
Other Study ID Numbers: NU 98X3
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Urinary Bladder Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases