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G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer

NCT00554463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-05-29

Study results available
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Summary

RATIONALE: 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 or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in treating neutropenia in patients undergoing combination chemotherapy and radiation therapy for limited stage small cell lung cancer.

Conditions

Interventions

DRUG

Filgrastim

5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.

DRUG

Pegfilgrastim

6 mg via subcutaneous injection days 46 and 67

DRUG

Etoposide

Concurrent: 120 mg/m\^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m\^2, IV on days 43-45 and days 65-66.

DRUG

Cisplatin

Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64.

RADIATION

radiation therapy

A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Rogerio C. Lilenbaum, MD · Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

  • Ritsuko U. Komaki, MD, FACR · M.D. Anderson Cancer Center

  • Michael A. Samuels, MD · CCOP - Mount Sinai Medical Center

  • Jeffrey Crawford, MD · Duke Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-08-31
Completion
2011-08-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554463 on ClinicalTrials.gov