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A Phase III Biomarker Validation Study of Second-line Therapy in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

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Trial Conditions
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
What is the purpose of this trial?

This randomized phase III trial is studying pemetrexed to see how well it works compared with erlotinib when given as second-line therapy in treating patients with advanced non-small cell lung cancer. Pemetrexed and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed is more effective than erlotinib in treating advanced non-small cell lung cancer

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Inclusion Criteria:

- Histologically confirmed non-small cell lung cancer (NSCLC), either oninitial
diagnosis or at the time of disease recurrence/progression

- Mixed histology allowed if all components are consistent with NSCLC

- Recurrent or progressive disease

- Measurable disease, defined as at least one lesion whose longest diameter can be
accurately measured as ≥ 2.0 cm by conventional techniques or as ≥ 1.0 cm by spiral
CT scan

- Measurable disease must be outside of any previously irradiated treatment
field(s) unless there is disease progression or recurrence within the irradiated

- No nonmeasurable disease only, defined as any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Single disease site in prior radiotherapy field

- Tumor tissue samples must be available and adequate for epidermal growth factor
receptor (EGFR) evaluation by FISH

- Previously treated with only one cytotoxic chemotherapy regimen for advanced disease

- Neoadjuvant/adjuvant cytotoxic chemotherapy administered< 12 months (from date
chemotherapy was started) prior to study entry will be counted as one prior

- Neoadjuvant/adjuvant chemotherapy administered ≥ 12 months prior to study entry
and use of targeted agents (e.g., monoclonal antibodies) will not be counted as
one prior treatment

- No symptomatic serosal effusion (≥ grade 2 dyspnea as measured by CTCAE v3.0) that is
not amenable to drainage

- No brain metastasis, unless the following criteria are met:

- Brain metastasis is stable and has been previously treated with either
whole-brain radiotherapy or gamma-knife surgery

- More than 14 days since prior steroid treatment

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Total bilirubin normal (ULN) OR direct bilirubinnormal

- AST and ALT ≤ 2.5 times ULN

- INR ≤ 1.5

- Creatinine clearance ≥ 45 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to take folic acid, vitamin B_12 supplementation, and dexamethasone

- No known HIV positivity

- No clinically significant infection

- No impaired gastrointestinal (GI) function, inability to swallow pills in the absence
of a feeding tube, or GI disease that may significantly alter absorption of oral
medications (e.g., ulcerative disease, uncontrolled nausea and vomiting,
malabsorption syndromes, or bowel obstruction)

- No serious condition that, in the opinion of the investigator, would preclude the
patient's ability to complete the study therapy or increase the risk for serious
adverse events

- No other invasive malignant solid tumor or hematologic malignancy, except for any of
the following:

- Prior carcinoma in situ, regardless of organ involvement, or nonmelanoma
cutaneous carcinoma that was definitively treated ≥ 3 years ago with no
subsequent evidence of recurrence

- Other prior malignancy diagnosed and definitively treated ≥ 5 years ago with no
subsequent evidence of recurrence

- Prior breast cancer that was definitively treated > 5 years ago allowed
provided patient is not receiving aromatase inhibitors

- Prio rlow-grade (Gleason score ≤ 6) localized prostate cancer that was
diagnosed < 3 years ago allowed

- Concurrent medications to maintain disease remission allowed

- No concurrent severe and/or uncontrolled medical condition, including any of the

- Angina pectoris

- Congestive heart failure within the past 3 months, unless ejection fraction >

- Myocardial infarction within the past 6 months

- Cardiac arrhythmia

- Diabetes mellitus

- Hypertension

- Any other severe underlying disease that, in the judgment of the investigator,
would preclude study entry

- No respiratory symptoms > CTCAE grade 1

- No significant traumatic injury within the past 4 weeks

- No concurrent prophylactic colony-stimulating factors

- Recovered from prior radiotherapy, except for alopecia

- No prior radiotherapy to > 25% of bone marrow

- No prior EGFR tyrosine kinase inhibitors or pemetrexed disodium

- More than 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)

- More than 2 weeks since prior immunotherapy, gene therapy, or other biologic therapy

- More than 2 weeks since prior limited-field radiotherapy (4 weeks for full-field

- More than 2 weeks since prior minor surgery*

- More than 4 weeks since prior major surgery (i.e., laparotomy)* or open biopsy

- More than 4 weeks since prior hormonal therapy

- More than 4 weeks since prior and no other concurrent ancillary therapy considered
investigational (i.e., utilized for a non-FDA-approved indication and in the context
of a research investigation)

- No aspirin dose ≥ 1.3 g/day for ≥ 10days before, during, and for ≥ 10 days after
treatment with pemetrexed disodium

- No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy

- Radiotherapy for symptom palliation (e.g., painful pre-existing bony metastasis)

- No other concurrent anticancer therapy

- No concurrent major surgery

- No concurrent antiretroviral therapy

Gender: Both
Steward Physician(s)
  • Alex Adjei
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
  • erlotinib hydrochloride
  • pemetrexed disodium
Physician Researcher

Investigator Name:

  • Alex Adjei

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00738881
Volunteers:  Not Accepting Healthy Volunteers

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