Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma

NCT00050674 | Completed Phase 2

• 1 other identifier: SD01-20010120
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when Filgrastim-SD/01 is given with docetaxel and gemcitabine in patients with advanced non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer, oncology, neutropenia, chemotherapy, filgrastim

Study Arms (1)

Filgrastim-SD/01

EXPERIMENTAL

6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion

Drug: Filgrastim-SD/01

Interventions

Filgrastim-SD/01 DRUG

6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)

Filgrastim-SD/01

Eligibility Criteria

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

* Histologically or cytologically documented non-small cell lung cancer * Subjects must have stage IV or IIIB NSCLC * 0-1 prior treatment regimens of chemotherapy * Subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies * Age \> 18 years * 1st Line - ECOG 0-2 * 2nd Line - ECOG 0-1 * Absolute neutrophil count \> or = 1.5 x 10 to the 9th power/L * Platelet count \> or = 100 x 10 to the 9th power/L * Adequate renal function with screening serum creatinine \< or = 2.0 mg/dL * Adequate AST and ALT no more than 1.5 x the upper limit of normal and serum bilirubin \< or = upper limit of normal * Subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments * Negative HCG by urine or blood test in subject of child-bearing potential * Life expectancy \> 2 months * Ethical - Before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study

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

Sponsors & Collaborators

• Schwartzberg, Lee, M.D.: lead
• Amgen: collaborator

Study Sites (2)

The West Clinic, PC

Southaven, Mississippi, 38671, United States

Location

The West Clinic, PC

Memphis, Tennessee, 38120, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasms; Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Lee S Schwartzberg, MD, FACP

  The West Clinic, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2002
• First Posted: December 18, 2002
• Study Start: November 1, 2001
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

US (2)