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A Phase I Dose-intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer


Phase 1
N/A
N/A
Open (Enrolling)
Both
Recurrent Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

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Trial Information

A Phase I Dose-intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT)
administered concomitantly with a fixed dose of cisplatin and etoposide within the same
overall treatment time.

OUTLINE: This is a dose-escalation study of radiation therapy.

Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated
radiotherapy (IMRT) 5 days a week for 8 weeks. Patients also receive cisplatin intravenously
(IV) over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5
and 28-32.

After completion of study treatment, patients are followed up at 8 weeks and 6 months.


Inclusion Criteria:



- Patients with confirmed unresectable Stage IIB or Stage III non-small cell lung
cancer of any histologic-subtype appropriate for definitive concurrent chemotherapy
and radiation as determined by multi-disciplinary assessment; all detectable tumor
should be encompassable by radiation therapy fields, including both the primary tumor
and the involved regional lymph nodes

- Granulocytes >= 1500/ul

- Platelets >= 100,000/ul

- Bilirubin < 1.5 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2
upper limit of normal (ULN)

- Creatinine clearance must be > 60ml/min

- Eastern Cooperative Oncology Group (ECOG) 0 to 1

- Weight loss =< 5% in the previous six months unless weight loss is intentional (per
judgment of study medical doctor [MD])

- Forced expiratory volume in one second (FEV1) must be >= 1.0 L

- Patients must sign a study-specific informed consent form prior to study entry

- Patients must have measurable disease on the 3D planning computed tomography (CT)

- Patient must have a completed 3D plan and the attending physician must have reviewed
and approved the dose volume histograms as follows: total lung volume percentage
receiving at least 20 Gy (V20) =< 35%, and mean lung dose =< 20 Gy

Exclusion Criteria:

- Mixed histology or undifferentiated small cell carcinoma, any stage

- Concurrent malignancy except non-melanomatous skin cancer or prior cancer if
disease-free for one year or more

- Patients with malignant pleural effusions or significant pericardial effusions

- Pregnant or lactating females

- Severe neuropathy greater than or equal to grade 2

- Severe sensorineural hearing loss greater or equal to grade 2

- No clinically significant history of cardiac disease, (i.e. uncontrolled
hypertension, unstable angina, congestive heart failure, myocardial infarction within
the past year, or cardiac ventricular arrhythmias requiring medication)

- Any significant or severe medical conditions or psychiatric or social conditions that
would preclude adherence to the protocol or compliance with study treatments

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose of radiotherapy, in terms of number of daily fractions, that can be delivered using 3D-CRT or IMRT with the standard cisplatin/etoposide regimen

Outcome Description:

The MTD will be the highest dose at which no more than one of six patients experience a dose-limiting toxicity (DLT). Toxicity will be scored using the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0.

Outcome Time Frame:

Up to 8 weeks after completion of radiotherapy

Safety Issue:

Yes

Principal Investigator

Shilpen Patel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

7506

NCT ID:

NCT01411098

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIB Non-small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109