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Study of Rapamycin Plus Ketoconazole in Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00708591
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Rapamycin Drug: Ketoconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study Administering Rapamycin (Sirolimus) With Ketoconazole in Patients With Advanced Malignancies
Study Start Date : October 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Rapamycin
Oral Rapamycin once weekly at assigned dose in 4 week cycles. Dosing can continue until disease progression or severe side effects are seen.
Other Names:
  • Rapamune
  • Sirolimus

Drug: Ketoconazole
Twice daily (200mg each time) at the start of the second week of therapy for 4 consecutive days. Dosing continues every week after the second week of therapy.

Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. observed toxicities [ Time Frame: 4 weeks ]
  2. anti-tumor response [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Patients with hematologic malignancies (lymphoma, multiple myeloma and CLL only) are eligible to participate in the phase Ib portion of the trial only
  • At least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last regimen included BCNU or mitomycin C).
  • Age >18 years.
  • ECOG performance status less than or equal to 2
  • Life expectancy of more than 3 months.
  • Normal organ and marrow function as defined below:

    • Hemoglobin ≥ 10 g/dl
    • Leukocytes ≥ 3,000/µL

      o WBC ≥ 1,500/µL for patients with hematologic malignancies

    • Absolute neutrophil count ≥ 1,500/µL (≥ 1,000/µL for patients with hematologic malignancies)
    • Absolute lymphocyte count ≥1000/µL
    • Platelets ≥ 100,000/µL (≥ 50,000/µL for patients with hematologic malignancies)
    • Total bilirubin within normal institutional limits
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional ULN
    • Serum triglycerides ≤ 500 mg/dl
    • Creatinine within normal institutional limits OR
    • Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Able to understand and the willing to sign a written informed consent document.

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Receiving any other investigational agents.
  • Uncontrolled brain metastases or malignancy.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Severe immunodeficient state (as judged by the treating physician)
  • Pregnancy (breast-feeding must be discontinued)
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with rapamycin.
  • Concurrent use of cyclosporine, tacrolimus, and rifampin, terfenadine, astemizole, cisapride, rosiglitazone or pioglitazone due to possible interactions with the study drugs. Ketoconazole cannot be taken within 2 hours of an antacid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708591

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Ezra Cohen, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00708591    
Other Study ID Numbers: 13274B
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors