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

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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