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A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Tumors, Neoplasm Metastasis

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Trial Information

A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies

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 chronic
lymphocytic leukemia (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

- Aged 18 years or older

- ECOG performance status 0-2

- Life expectancy of greater than 3 months.

- Normal organ and marrow function:

- No transfusions of packed red blood cells within 1 week of starting treatment

- Leukocytes greater or equal to 3,000/μL

** White blood cell (WBC) greater or equal to 1,500/μL for patients with
hematologic malignancies

- Absolute neutrophil count (ANC) greater or equal to 1,500/μL

** ANC greater or equal to 1,000/μL for patients with hematologic malignancies

- Platelets (PLT) greater or equal to 100,000/μL

** PLT greater or equal to 50,000/μL for patients with hematologic malignancies

- Total bilirubin within normal institutional limits

- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times institutional upper
limit of normal

- Serum triglycerides less than or equal to 500 mg/dl

- Creatinine within normal institutional limits OR creatinine clearance greater or
equal to 60 mL/min for patients with creatinine levels above institutional

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence)

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to entering the study or those who have not recovered from adverse events due
to agents administered more than 4 weeks earlier.

- May not be receiving any other investigational agents.

- Uncontrolled brain metastases or malignancy. Cannot be receiving enzyme-inducing

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to rapamycin

- Gastrointestinal malabsorption syndromes, partial small bowel obstruction, or any
illness that would interfere with the ability to absorb oral medications.

- Uncontrolled intercurrent illness

- Severe immunodeficient states (as judged by the treating physician)

- Pregnant women are excluded from this study; breastfeeding should be discontinued.

- HIV-positive patients receiving combination antiretroviral therapy are excluded.

- Concurrent use of ketoconazole, cyclosporine, tacrolimus, diltiazem, and rifampin
with rapamycin is not permissible. The concurrent use of calcium channel blockers,
terfenadine, astemizole, cisapride, propafenone, cyclosporine, midazolam, triazolam,
quinidine, or theophylline with grapefruit juice is not permissible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic interaction

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Ezra W Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

November 2013

Related Keywords:

  • Tumors
  • Neoplasm Metastasis
  • phase I
  • metastatic
  • advanced cancer
  • lung cancer
  • renal cancer
  • kidney cancer
  • head and neck cancer
  • bladder cancer
  • breast cancer
  • colorectal cancer
  • esophagus
  • GIST
  • liver cancer
  • melanoma
  • mesothelioma
  • lymphoma
  • ovary cancer
  • ovarian cancer
  • pancreas cancer
  • pancreatic cancer
  • prostate cancer
  • stomach cancer
  • thyroid cancer
  • Metastatic solid tumor
  • Neoplasms
  • Neoplasm Metastasis



University of Chicago Hospitals Chicago, Illinois  60637