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A Phase I Study of Temsirolimus and Thoracic Radiation in Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase I Study of Temsirolimus and Thoracic Radiation in Non-Small Cell Lung Cancer (NSCLC)

Temsirolimus has demonstrated anti-proliferative and anti-angiogenic activity in multiple
epithelial cancers, is well-tolerated, has non-overlapping toxicities with radiation, and
has been shown to potentiate the effects of radiation in vitro. Locally advanced non-small
cell lung cancer is cured in a minority of patients with concurrent chemoradiation but newer
agents are needed. In this study temsirolimus will be studied in combination with radiation
in a phase I setting to establish safety.

Inclusion Criteria:

- Patients must have a histologically or cytologically confirmed diagnosis of NSCLC.

- Patients must have an indication for thoracic radiation.

- Because all patients will be receiving radiation therapy to a thoracic mass, they
must have radiographically measurable disease to participate.

- Patients may not be candidates for definitive chemoradiation with curative intent.

- Prior treatment of lung cancer (chemotherapy, radiation therapy, and surgery) are
allowed if completed at least 4 weeks prior and if all treatment related toxicities
are resolved.

- At least 18 years of age.

- Life expectancy of > 12 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Patients must have adequate organ and marrow function as defined below:

- leukocytes ≥3,000/mcL

- absolute neutrophil count ≥1,500/mcL

- platelets ≥100,000/mcL

- total bilirubin < 1.5

- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal

- creatinine within normal institutional limits OR

- creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal

- The effects of temsirolimus on the developing human fetus at the recommended
therapeutic dose are unknown. For this reason, women of child-bearing 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. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

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

Exclusion Criteria:

- Patients who have had prior treatment with temsirolimus.

- Patients may not be receiving any other investigational agents.

- Patients with symptomatic brain metastases. Known brain metastases are allowed if
asymptomatic and previously treated.

- Patients may not be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g.,
phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as
rifampin or St. John's wort, as these may decrease temsirolimus levels. A partial
list of agents which interact with cytochrome P450 (CYP3A) is found in Appendix B.
Use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels),
such as ketoconazole, is discouraged, but not specifically prohibited. Temsirolimus
can inhibit CYP2D6, and may decrease metabolism (and increase drug levels) of drugs
that are substrates for CYP2D6, such as codeine. The appropriateness of use of such
agents is left to physician discretion. A list of drugs that may have potential
interactions with CYP2D6 is found in Appendix B. If there is any doubt about
eligibility based on concomitant medication, the Principal Investigator should be
contacted. All concomitant medications must be recorded.

- Patients with known hypersensitivity reactions to macrolide antibiotics (such as
erythromycin, clarithromycin, and azithromycin).

- 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.

- Known HIV-positive patients on combination antiretroviral therapy are ineligible
because of the potential for pharmacokinetic interactions. In addition, these
patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy. Appropriate studies will be undertaken in patients
receiving combination antiretroviral therapy when indicated.

- Patients having received prior thoracic radiation therapy directed to the tumor
volume to be treated with radiotherapy on this protocol.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerate dose of temsirolimus given with radiation

Outcome Time Frame:

60 days

Safety Issue:


Principal Investigator

Maria Q. Baggstrom, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:

08-1259 / 201012882



Start Date:

March 2009

Completion Date:

March 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-small cell lung cancer
  • temsirolimus
  • radiation therapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110