Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

OUTLINE: This is a multicenter study.

Patients undergo thoracic radiotherapy once daily on days 1-5 of weeks 1-3 and twice daily
on days 1-5 of weeks 4 and 5 for a total of 16 fractions. Patients also receive concurrent
chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy
repeats every 3 weeks for 2 courses. Patients receive filgrastim (G-CSF) subcutaneously (SC)
on days 4-13 and 25-34.

After completion of chemoradiotherapy, patients receive adjuvant chemotherapy comprising
cisplatin IV on day 1 and etoposide IV on days 2 and 3. Adjuvant therapy repeats every 21
days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients also receive pegfilgrastim SC on day 4 of each course of adjuvant therapy.

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.

Inclusion Criteria


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 ≥ 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 or ALT ≤ 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)

- Creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- Must have best value of FEV1 ≥ 1.5 liters/second obtained on two measurements taken
before and after use of a bronchodilator

- 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 < 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

- 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Incidence of grade 4 neutropenia or grades 3-4 febrile neutropenia episodes during concurrent chemoradiotherapy as assessed by NCI CTCAE v 3.0

Outcome Time Frame:

At the completion of all treatment, approximately 80 days

Safety Issue:

Yes

Principal Investigator

Rogerio C. Lilenbaum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

Authority:

United States: Federal Government

Study ID:

RTOG 0623

NCT ID:

NCT00554463

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295