Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

NCT00028925 | Completed Phase 2

• 3 other identifiers: NCCTG-N0027NCI-2012-02441CDR0000069147
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 24

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• response rate

  Up to 5 years

Secondary Outcomes (1)

• overall survival

  Up to 5 years

Study Arms (2)

Regimen A

EXPERIMENTAL

Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Biological: filgrastim; Drug: carboplatin; Drug: topotecan hydrochloride; Radiation: WBRT

Regimen B

EXPERIMENTAL

Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A. Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes. Quality of life is assessed at baseline and at the beginning of each course of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Biological: filgrastim; Drug: carboplatin; Drug: topotecan hydrochloride; Radiation: WBRT

Interventions

filgrastim BIOLOGICAL

Regimen A; Regimen B

carboplatin DRUG

Regimen A; Regimen B

topotecan hydrochloride DRUG

Regimen A; Regimen B

WBRT RADIATION

Regimen A; Regimen B

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer * Previously untreated with chemotherapy * No mixed histology * Metastatic disease outside the chest * Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR * Cytologically proven malignant pleural effusion * Measurable disease * No untreated CNS metastases * CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * Bilirubin no greater than 1.5 times ULN OR * Direct bilirubin no greater than ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No uncontrolled angina pectoris * No congestive heart failure within the past 3 months unless ejection fraction is greater than 40% * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant infection * No hypersensitivity to E. coli-derived proteins * No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 5 years since prior chemotherapy for another malignancy * No prior nitrosoureas Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior thoracic radiotherapy * At least 1 day since prior palliative radiotherapy (except to chest) * No more than 3 fractions to chest for superior vena cava syndrome allowed * No concurrent radiotherapy (including thoracic radiotherapy) Surgery: * More than 3 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (24)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

MBCCOP-Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Wichita Community Clinical Oncology Program

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Bryce AH, Mattar B, Hillman SL, Adjei AA, Kugler JW, Rowland K Jr, Wender DB, Soori G, Perez EA, Jett JR. Phase II trial of oral topotecan and intravenous carboplatin with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: A North Central Cancer Treatment Group Study. Am J Clin Oncol. 2010 Aug;33(4):353-7. doi: 10.1097/COC.0b013e3181b0c27f.

  PMID: 19935387 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Filgrastim; Carboplatin; Topotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• James R. Jett, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: June 30, 2003
• Study Start: November 1, 2001
• Primary Completion: November 1, 2005
• Study Completion: August 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (23); CA (1)