Brief Title
Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer
Brief Summary
This phase II trial is studying how well docetaxel given together with cisplatin and
pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB
or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and
cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Colony stimulating factors, such as 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. Erlotinib hydrochloride may
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride
may kill more tumor cells
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if this regimen improves the time-to-progression for patients with advanced
non-small cell lung cancer (NSCLC) compared to historical controls.
SECONDARY OBJECTIVES:
I. To assess response rate and median survival. II. To evaluate tumor biomarkers that could
predict response and survival for patients treated with this regimen including endothelial
growth factor receptor (EGFR) expression, EGFR Fluorescence in situ hybridization (FISH), and
k-ras mutations.
III. To evaluate genetic polymorphisms as markers of response and survival for patients
treated with this regimen including polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 1 hour
on day 1, and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for
4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks
after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive erlotinib
hydrochloride orally (PO) once daily (QD) in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
every 6 months for 2 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Time to Progression
Secondary Outcome
Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood
Condition
Adenocarcinoma of the Lung
Intervention
cisplatin
Study Arms / Comparison Groups
Treatment (chemo, chemoprotection, antiangiogenesis therapy)
Description: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
45
Start Date
July 2007
Completion Date
February 2011
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- Histologic Documentation: Either histologic or cytologic documentation of non-small
cell carcinoma (NSCLC) is necessary, and the following diagnostic categories are
acceptable: squamous carcinoma, basaloid carcinoma, adenocarcinoma, bronchioloalveolar
carcinoma, adenosquamous carcinoma, large cell carcinoma (not neuroendocrine),
sarcomatoid carcinoma, and non-small cell carcinoma not otherwise specified (NOS);
histologic or cytologic documentation of recurrence is required in patients who were
previously completely resected
- Advanced Disease: Stage IIIB because of malignant pleural or pericardial effusion or
stage IV disease
- Patients must be ineligible for Avastin or decline treatment with Avastin
- Prior Treatment: No prior chemotherapy or treatment with an EGFR inhibitor is allowed;
brain metastasis must be under control (patient neurologically stable)
- All Patients must have Measurable or Non-Measurable Disease: measurable disease is
defined as at least one lesion that can be accurately measured in at least one
dimension; the longest diameter of measurable lesions must be >= 20 mm with
conventional techniques or >= 10 mm with spiral computed tomography (CT) scan;
non-measurable disease includes the following:
- Bone lesions
- Brain metastasis or leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Granulocytes >= 1,500/ul
- Platelets >= 100,000/ul
- Creatinine =< upper limit of normal (ULN)
- Bilirubin =< 1.5 mg/dl
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase
[AST]) =< 1.5 x ULN
- Alkaline (Alk.) phosphatase (phos.) =< 2.5 x ULN
- Patients must provide verbal and written informed consent to participate in the study
Exclusion Criteria:
- Patients who are pregnant or nursing because of significant risk to the fetus/infant
- Patients with neuropathy >= grade 2
- Patients with a psychiatric illness which would prevent the patient from giving
informed consent
- Patients who are unable to take oral medications
- Women with child-bearing potential or men who are sexual partners of women with
child-bearing potential who are not willing to practice adequate contraceptive
measures
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
William Petty, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01557959
Organization ID
CCCWFU 62107
Secondary IDs
NCI-2009-01252
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
William Petty, Principal Investigator, Wake Forest University Health Sciences
Verification Date
May 2018