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Lung CancerPhase 2NCT00554463

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

A Phase 2 study testing Filgrastim, Pegfilgrastim and Etoposide in people with Lung Cancer, run by Radiation Therapy Oncology Group at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Filgrastim, Pegfilgrastim and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
14 sitesUnited States
Study dates
Jan 2008to 3 Aug 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell carcinoma of the lung
  • Limited stage disease, defined as any of the following:
  • Tumor confined to one hemithorax
  • T4 tumor not based on malignant pleural effusion
  • N3 disease not based on contralateral supraclavicular involvement
  • No complete tumor resection
  • Measurable or evaluable disease
  • Pleural effusion allowed provided the following conditions are present:
  • Effusion is too small to tap under CT guidance and is not evident on chest x-ray
  • Effusion appears only after a thoracotomy or other invasive procedure
  • Must have certification by a Radiation Oncologist that the tumor can be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • ANC (absolute neutrophil count) ≥ 1,800 cells/mm³
  • Platelet count ≥ 100,000 cells/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
  • Total bilirubin ≤ 1.5 mg/dL
  • AST (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 2 times the upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN (< 5 times ULN if judged by the investigator to be related to liver metastases)
  • Serum creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5 liters/second
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 60 days after the last study treatment
  • No prior invasive malignancy, except non-melanomatous skin cancer or other micro-invasive malignancy, or carcinoma in situ of the breast, oral cavity, or cervix, unless the patient has been disease-free for a minimum of 3 years
  • No weight loss > 5% for any reason within the past 3 months
  • No severe, active comorbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • Chronic Obstructive Pulmonary Disease exacerbation with FEV1 (forced expiratory volume) < 1.5 liters/second or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS (HIV testing not required for entry into this protocol)
  • No prior allergic reaction to the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for lung cancer
  • Prior chemotherapy for a different cancer is allowed, provided it was completed ≥ 5 years prior to registration
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No concurrent intensity-modulated radiotherapy
  • No concurrent amifostine

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • Cancer Treatment Center

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer

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.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.

Secondary

  • To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising cisplatin and etoposide.
  • To estimate the incidence of dose modifications or treatment delays in patients treated with this regimen.
  • To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events in patients treated with this regimen.
  • To estimate the incidence of grade 4 thrombocytopenia in patients treated with this regimen.
  • To estimate the median and two-year rate of progression-free and overall survival of patients treated with this regimen.

After completion of study therapy, patients are followed every 3 months for one year, every 6 months for 2-3 years, and then annually for up to 5 years.

Conditions
Lung Cancer
Being tested
Filgrastim, Pegfilgrastim, Etoposide, Cisplatin, radiation therapy
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgrastimDrug

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

  • PegfilgrastimDrug

    6 mg via subcutaneous injection days 46 and 67

  • EtoposideDrug

    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.

  • CisplatinDrug

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

  • radiation therapyRadiation

    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.

Study groups in NCT00554463
Study groupRoleWhat they receive
Combined Modality Therapy with Growth Factor SupportExperimentalConcurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Receives: Drug: Filgrastim; Drug: Pegfilgrastim; Drug: Etoposide; Drug: Cisplatin; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

    Measured: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days

Secondary outcomes (6)

  1. Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

    Measured: From the start to the end of adjuvant chemotherapy, a maximum of 24 days

  2. Number of Patients With Dose Modifications or Treatment Delays

    Measured: From start of treatment to end of treatment, for a maximum of 66 days

  3. Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

    Measured: From registration to last follow-up, a maximum of 32.9 months

  4. Number of Patients With Grade 4 Thrombocytopenia

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

    Measured: From registration to last follow-up, a maximum of 32.9 months

  5. Overall Survival

    Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated.

    Measured: From registration to last follow-up, a maximum of 32.9 months

  6. Progression-free Survival

    Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated.

    Measured: From registration to last follow-up, a maximum of 32.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2011
  4. Study completion3 Aug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554463
Sponsor's protocol ID
RTOG 0623
Other IDs
CDR0000574000, NCI-2009-00742
Status last verified
May 2019
First submitted
6 Nov 2007
Last updated
29 May 2019
Data monitoring committee
Yes

Publications

  • Lilenbaum R, Samuels M, Taffaro-Neskey M, Cusnir M, Pizzolato J, Blaustein A. Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):837-40. doi: 10.1097/JTO.0b013e3181d6e141.

    PubMed 20421820

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgrastim, Pegfilgrastim and Etoposide in people with Lung Cancer, run by Radiation Therapy Oncology Group at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy (time frame: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00554463, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

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