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CCI-779 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00003712
First received: November 1, 1999
Last updated: August 7, 2012
Last verified: August 2012

November 1, 1999
August 7, 2012
January 2001
June 2002   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00003712 on ClinicalTrials.gov Archive Site
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CCI-779 in Treating Patients With Advanced Solid Tumors
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.

OBJECTIVES:

  • Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in patients with advanced solid tumors (part I) who are not receiving anticonvulsant therapy.
  • Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy.
  • Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients.

OUTLINE: This is an open-label, dose-escalation study.

  • Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.

  • Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: temsirolimus

•Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.

•Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2002
June 2002   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

Part I:

  • Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists
  • No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I)
  • Measurable or evaluable disease

Part II:

  • Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists
  • Receiving anticonvulsants
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases)

Renal:

  • Creatinine less than 2 mg/dL

Cardiovascular:

  • No unstable angina
  • No myocardial infarction within past 6 months
  • No maintenance therapy for life-threatening arrhythmias

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection or other serious concurrent illness
  • Triglycerides no greater than 300 mg/dL
  • Cholesterol no greater than 350 mg/dL
  • No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 1 month since prior investigational agents
  • At least 3 weeks since prior immunosuppressive therapy
  • No concurrent anticonvulsant therapy (part I)
  • No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide)
  • No known agents that inhibit or induce cytochrome p450
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003712
CDR0000066820, P30CA054174, UTHSC-9785011303, SACI-IDD-98-02, W-AR-3066K1-100-US, NCI-V98-1506
Yes
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
  • National Cancer Institute (NCI)
  • University of Texas
  • Wyeth is now a wholly owned subsidiary of Pfizer
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
The University of Texas Health Science Center at San Antonio
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP