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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Northwestern University Identifier:
First received: December 10, 1999
Last updated: January 28, 2011
Last verified: January 2011

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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Study Start Date: August 1999
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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: Albert B. Benson, MD, Northwestern University Identifier: NCT00004095     History of Changes
Other Study ID Numbers: NU 98X3
Study First Received: December 10, 1999
Last Updated: January 28, 2011

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:
Lung Neoplasms
Breast Neoplasms
Pancreatic Neoplasms
Colorectal Neoplasms
Urinary Bladder Neoplasms
Kidney Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases processed this record on March 27, 2017