S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

This study has been terminated.
(Closed due to poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00265785
First received: December 14, 2005
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 0 - 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 0 - 3 years ] [ Designated as safety issue: No ]
    Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

  • Response (Confirmed and Unconfirmed, Complete and Partial) [ Time Frame: Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years. ] [ Designated as safety issue: No ]
    Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

  • Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment. ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.


Enrollment: 27
Study Start Date: July 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed
pemetrexed
Drug: pemetrexed
Pemetrexed 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Other Name: Alimta

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 disease
  • Measurable disease or nonmeasurable disease documented by CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No more than 2 prior systemic therapies (including epidermal growth factor receptor inhibitor)
  • At least 28 days since prior systemic therapy
  • Patients treated with prior erlotinib or gefitinib must have shown progression since treatment
  • 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 treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265785

  Show 112 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Derick H. Lau, MD University of California, Davis
Principal Investigator: Rachel E. Sanborn, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00265785     History of Changes
Other Study ID Numbers: CDR0000456424, U10CA032102, S0526
Study First Received: December 14, 2005
Results First Received: July 12, 2012
Last Updated: October 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
bronchoalveolar cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 22, 2014