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A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer


OBJECTIVES:

- Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and
irinotecan in patients with advanced cancer.

- Determine the objective antitumor responses in patients treated with this regimen.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days
1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable
toxicity.

Sequential dose escalation of epirubicin is followed by sequential dose escalation of
irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan
until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically documented incurable malignancy for which there is no beneficial
standard therapy

- Locally unresectable or metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 8 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.2 times upper limit of normal (ULN)

- SGOT and SGPT no greater than 2 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- Ejection fraction at least 50% by MUGA scan

- No congestive heart failure

Other:

- Maintaining a reasonable state of nutrition

- No frequent vomiting or severe anorexia

- No weight loss greater than 10% of current body weight within the past 4 weeks

- No other concurrent medical illness that would preclude study

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2

Endocrine therapy:

- Not specified

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- Recovered from prior therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John L. Marshall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068710

NCT ID:

NCT00020748

Start Date:

August 2000

Completion Date:

October 2004

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007