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Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

William Petty

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 62107

NCT ID:

NCT01557959

Start Date:

July 2007

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157