Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062127
First received: June 5, 2003
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Drug: thalidomide
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effect of thalidomide on irinotecan hydrochloride pharmacokinetics [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours ] [ Designated as safety issue: No ]
  • Effect of irinotecan hydrochloride on thalidomide pharmacokinetics [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours ] [ Designated as safety issue: No ]
  • Grade 3 or greater toxicities assessed using NCI CTC version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.

  • Response assessed using RECIST criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Will be summarized and analyzed using descriptive statistics. Exact 90% confidence intervals using the binomial distribution will be derived.


Enrollment: 35
Study Start Date: April 2003
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (irinotecan hydrochloride and thalidomide)
Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Arm II (irinotecan hydrochloride and thalidomide)
Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.

II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.

III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.

Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7.

All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed malignant solid tumor

    • Metastatic or unresectable
    • Standard curative or palliative therapy is no longer effective or does not exist
  • Measurable or assessable disease
  • No uncontrolled brain metastases

    • Patients with brain metastases are eligible provided the following are true:

      • Stable neurologic status
      • At least 4 weeks since prior steroids or anticonvulsants
      • No neurologic dysfunction that would confound evaluation
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of inflammatory bowel disease requiring therapy
  • No chronic diarrhea syndromes
  • No paralytic ileus
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation
  • Male patients must use effective barrier contraception during and for 4 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No uncontrolled seizure disorder
  • No other concurrent uncontrolled illness that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No ongoing or active infection
  • No significant traumatic injury within the past 28 days
  • No serious, nonhealing wounds or ulcers
  • No bone fractures
  • No preexisting peripheral neuropathy grade 2 or greater
  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • More than 28 days since prior major surgical procedure or open biopsy
  • At least 4 weeks since prior investigational therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  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: NCT00062127

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Ratain University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062127     History of Changes
Other Study ID Numbers: NCI-2012-02537, 12044B, U01CA069852, CDR0000304517
Study First Received: June 5, 2003
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Thalidomide
Irinotecan
Camptothecin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014