Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT01411098 | Terminated Phase 1

• 3 other identifiers: 7506NCI-2011-01752P30CA015704
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of radiation therapy when given together with cisplatin and etoposide in treating patients with non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and etoposide may kill more tumor cells.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 8 weeks after completion of radiotherapy

Study Arms (1)

Treatment (radiation therapy and chemotherapy)

EXPERIMENTAL

Patients undergo 3D-CRT or IMRT 5 days a week for 8 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5, and 28-32.

Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Drug: etoposide

Interventions

3-dimensional conformal radiation therapy RADIATION

Undergo 3D-CRT

Also known as: 3D conformal radiation therapy, 3D-CRT

Treatment (radiation therapy and chemotherapy)

intensity-modulated radiation therapy RADIATION

Undergo IMRT

Also known as: IMRT

Treatment (radiation therapy and chemotherapy)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (radiation therapy and chemotherapy)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (radiation therapy and chemotherapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Shilpen Patel

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (1)