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Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)



- Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar
carcinoma treated with pemetrexed disodium.


- Evaluate the progression-free survival of patients treated with this drug.

- Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the
subset of patients with measurable disease treated with this drug using standard RECIST
criteria and computer assisted image analysis.

- Evaluate frequency and severity of toxicities in patients treated with this drug.

- Perform molecular correlative studies on patient tissue to investigate potential
predictors of efficacy. (This will not be completed as this study was closed due to
poor accrual.)

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib
(yes vs no).

Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as
adenocarcinoma with BAC features or BAC with invasive adenocarcinoma

- Cytology specimens, such as bronchial brushings, washings, or fine needle
aspiration specimens alone are not acceptable for diagnosis

- Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion
only], any N, M0) disease

- Incompletely resected or unresectable disease

- Pleural effusions, ascites, or laboratory parameters cannot be only evidence of

- Measurable disease or nonmeasurable disease documented by CT scan

- No known brain metastases


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 2.5 times ULN ( ≤ 5 times ULN if due to liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN ( ≤ 5 times ULN if due to bone metastases)

- Creatinine clearance ≥ 45 mL/min OR creatinine ≤ 1.5 times ULN

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm³

- Zubrod 0-2

- No history of allergic reaction to compounds of similar chemical or biological
composition as pemetrexed disodium

- Must provide smoking history

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to swallow pills


- No more than 2 prior systemic therapies (including epidermal growth factor receptor

- At least 28 days since prior systemic therapy

- Patients treated with prior erlotinib or gefitinib must have shown progression since

- No prior pemetrexed disodium

- At least 28 days since prior radiotherapy and recovered

- Must have measurable or nonmeasurable disease outside previously irradiated area
or a new lesion within previously irradiated area

- At least 14 days since prior palliative radiotherapy and recovered

- At least 28 days since prior thoracic or major surgery and recovered

- No concurrent surgery

- No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease

- No concurrent antiretroviral therapy

- Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with
longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium,
oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib,
meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome Time Frame:

0 - 3 years

Safety Issue:


Principal Investigator

Derick H. Lau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

July 2006

Completion Date:

July 2011

Related Keywords:

  • Lung Cancer
  • bronchoalveolar cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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