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
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 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
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 October 19, 2014