Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT ID: NCT01557959

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-02-28

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.

Conditions

Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

pegfilgrastim

Intervention Type: BIOLOGICAL

Given SC

erlotinib hydrochloride

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Optional correlative study

polymorphism analysis

Intervention Type: GENETIC

Correlative study

pharmacogenomic studies

Intervention Type: OTHER

Correlative study

genetic linkage analysis

Intervention Type: GENETIC

Correlative study

docetaxel

Intervention Type: DRUG

Given IV

Interventions

cisplatin

Given IV

Intervention Type: DRUG

pegfilgrastim

Given SC

Intervention Type: BIOLOGICAL

erlotinib hydrochloride

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Optional correlative study

Intervention Type: OTHER

polymorphism analysis

Correlative study

Intervention Type: GENETIC

pharmacogenomic studies

Correlative study

Intervention Type: OTHER

genetic linkage analysis

Correlative study

Intervention Type: GENETIC

docetaxel

Given IV

Intervention Type: DRUG

Other Intervention Names

CACP; CDDP; CPDD; DDP; Filgrastim SD-01; GCSF-SD01; Neulasta; SD-01 sustained duration G-CSF; CP-358,774; erlotinib; OSI-774; Pharmacogenomic Study; linkage analysis; RP 56976; Taxotere; TXT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Petty

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

Petty WJ, Laudadio J, Brautnick L, Lovato J, Dotson T, Streer NP, Weaver KE, Miller AA. Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer. Int J Oncol. 2013 Dec;43(6):2057-63. doi: 10.3892/ijo.2013.2122. Epub 2013 Oct 3.

Reference Type: DERIVED

PMID: 24100924 (View on PubMed)

Other Identifiers

NCI-2009-01252

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 62107

Identifier Type: -

Identifier Source: org_study_id

NCT00723138

Identifier Type: -

Identifier Source: nct_alias