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

NCT01557959 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CCCWFU 62107NCI-2009-01252
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  2 years

Secondary Outcomes (2)

• Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood

  2 years

• Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood

  2 years

Study Arms (1)

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

EXPERIMENTAL

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.

Drug: cisplatin; Biological: pegfilgrastim; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Genetic: polymorphism analysis; Other: pharmacogenomic studies; Genetic: genetic linkage analysis; Drug: docetaxel

Interventions

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

pegfilgrastim BIOLOGICAL

Given SC

Also known as: Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

erlotinib hydrochloride DRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

laboratory biomarker analysis OTHER

Optional correlative study

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

polymorphism analysis GENETIC

Correlative study

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

pharmacogenomic studies OTHER

Correlative study

Also known as: Pharmacogenomic Study

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

genetic linkage analysis GENETIC

Correlative study

Also known as: linkage analysis

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (chemo, chemoprotection, antiangiogenesis therapy)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 24100924 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; pegfilgrastim; Erlotinib Hydrochloride; Amplified Fragment Length Polymorphism Analysis; Pharmacogenomic Testing; Genetic Linkage; Docetaxel

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Genetic Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. William J. Petty
• Organization: Wake Forest Baptist Health

wpetty@wakehealth.edu

336-716-3313

Study Officials

• William Petty

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 20, 2012
• Study Start: July 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 29, 2018
• Results First Posted: June 28, 2013

Record last verified: 2018-05

Locations

US (1)