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Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Bladder Cancer, Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer

Thank you

Trial Information

Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors


- 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

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

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Al B. Benson, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 98X3



Start Date:

August 1999

Completion Date:

October 2008

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Kidney Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • 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



Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611