Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054288
First received: February 5, 2003
Last updated: January 10, 2014
Last verified: January 2014
  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 with gemcitabine in treating patients who have refractory advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: August 2001
Study Completion Date: June 2009
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors.
  • Determine the antitumor activity and toxicity of this regimen in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
  • Determine the optimal dose and time interval for this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment

    • Considered incurable with other modalities
  • Measurable or evaluable disease

    • The following are not considered measurable or evaluable:

      • Bone metastases
      • Pleural, pericardial, or peritoneal effusions
      • Irradiated lesions (unless progression is documented after radiotherapy)
    • Metastatic disease that has been followed using serum tumor markers allowed
  • No symptomatic brain metastases
  • Brain metastases may not be sole site of metastatic disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • AST and ALT no greater than 1.5 times normal
  • Bilirubin no greater than 1.5 mg/dL
  • No clinically apparent jaundice

Renal

  • Creatinine no greater than 1.6 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • Cardiac function normal
  • No uncontrolled heart disease
  • No myocardial infarction within the past 3 months
  • No congestive heart failure
  • No unstable or uncontrolled angina

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infection requiring systemic therapy
  • No uncontrolled seizures
  • No uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior gemcitabine
  • No prior camptothecin compounds
  • Prior irinotecan allowed
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 14 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior clinical trial participation
  • No other concurrent investigational medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054288

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Nithya Ramnath, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Nithya Ramnath, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00054288     History of Changes
Other Study ID Numbers: CDR0000270343, RPCI-DS-01-18
Study First Received: February 5, 2003
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014