Trial record 1 of 1 for:    NCT00660816
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Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00660816
First received: April 16, 2008
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

RATIONALE: Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving pemetrexed disodium or docetaxel together with erlotinib hydrochloride is more effective than giving pemetrexed disodium or docetaxel alone in treating non-small lung cancer.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium or docetaxel together with or without erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial, Comparing Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Plus Erlotinib to Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]
    From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]
    Measured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors

  • Response rate [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]
    Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution

  • Disease stabilization rate (e.g., complete response, partial response, and stable disease) [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]
    Estimated based on number of complete response, partial response or stable disease


Enrollment: 46
Study Start Date: January 2008
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV over 10 minutes on day 1
Other Name: MTA
Drug: docetaxel
IV over 60 minutes on day 1.
Other Name: TXT
Experimental: Arm II
Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1 and erlotinib hydrochloride PO once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Given orally once daily on days 2-19.
Other Name: erlotinib
Drug: pemetrexed disodium
Given IV over 10 minutes on day 1
Other Name: MTA
Drug: docetaxel
IV over 60 minutes on day 1.
Other Name: TXT

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate whether maintenance erlotinib hydrochloride added to standard of care (pemetrexed disodium or docetaxel) chemotherapy in patients with erlotinib hydrochloride-responsive advanced non-small cell lung cancer leads to an improved progression-free survival as compared to standard of care pemetrexed disodium or docetaxel alone.

Secondary

  • To evaluate the effect of maintenance erlotinib hydrochloride on the response rate to standard of care (pemetrexed disodium or docetaxel) therapy in patients with erlotinib hydrochloride-responsive advanced non-small cell lung cancer as compared to standard of care (pemetrexed disodium or docetaxel) alone.
  • To evaluate whether maintenance erlotinib hydrochloride added to standard of care (pemetrexed disodium or docetaxel) chemotherapy in patients with erlotinib hydrochloride-responsive advanced non-small cell lung cancer leads to an improved overall survival as compared to standard of care (pemetrexed disodium or docetaxel) alone.
  • To evaluate the effect of maintenance erlotinib hydrochloride on the disease stabilization (complete response [CR] + partial response [PR] + stable disease [SD]) rate to standard of care (pemetrexed disodium or docetaxel) therapy in patients with erlotinib hydrochloride-responsive advanced non-small cell lung cancer as compared to standard of care (pemetrexed disodium or docetaxel) alone.
  • To evaluate the utility of early positron emission tomography (PET) scanning (baseline versus 1 cycle of protocol therapy) on overall disease assessment and prediction of treatment responsiveness.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to lifetime smoking status (never vs ever) and ECOG performance status (0-1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: (standard of care alone): Patients receive pemetrexed disodium intravenously (IV) over 10 minutes OR docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: (standard of care plus erlotinib): Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1 and erlotinib hydrochloride orally (PO) once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 8 weeks.

  Eligibility

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

INCLUSION CRITERIA

  • Pathologic diagnosis of stage IIIB (with pleural effusion) or IV non-small cell lung cancer
  • Progression following at least twelve weeks of treatment with single-agent erlotinib (or in combination with other experimental agents) during which time the patients experienced a clinical benefit as assessed by his/her treating physician and corroborated by radiographic assessment (at least one CT scan following at least 4 weeks of erlotinib monotherapy demonstrating stable disease or response on erlotinib therapy).
  • At least one measurable lesion as defined by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy of at least 12 weeks
  • Absolute neutrophil count (ANC) >= 1.5x10(9)/L
  • Platelet count >= 100x 10(9)
  • Hemoglobin >= 8.0 g/dl
  • Serum creatinine =< 1.5 upper limit of normal OR calculated creatinine clearance >= 45 mL/min
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Available baseline diagnostic tumor specimen for correlative studies, any diagnostic material will be acceptable- paraffin block, cell block, fine needle aspirate etc.
  • Patients must provide verbal and written informed consent to participate in the study
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Patient must be able to take folic acid, vitamin B12 as well as dexamethasone therapy as per protocol guidelines
  • Patient must be able to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed (this exclusion criteria applies only to patients who have not received pemetrexed chemotherapy prior)

EXCLUSION CRITERIA

  • Active central nervous system disease (CNS) metastases, as indicated by clinical symptoms, cerebral edema or progressive growth (subjects with a clinical history of CNS metastases or cord compression are allowable if they have been definitively treated and are clinically stable for at least 4 weeks before first dose of study treatment for prior whole brain radiation and 2 weeks for prior gamma knife therapy)
  • More than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease (not including erlotinib)
  • Any prior epidermal growth factor receptor (EGFR) inhibitor therapy except for erlotinib
  • Major surgery, chemotherapy, or investigational agents within 3 weeks of treatment day 1 (except for erlotinib). Radiation therapy within 2 weeks of treatment day 1 (except for erlotinib).
  • Prior treatment with both pemetrexed and docetaxel chemotherapy
  • Pregnancy or breastfeeding or not receiving adequate contraception (including the patients spouse)
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
  • Patients who must receive pemetrexed and have the presence of third space fluid which cannot be controlled by drainage
  • Patients who must receive docetaxel and who have peripheral neuropathy > grade 2
  • Patients who must receive docetaxel and who have had a hypersensitivity reaction to medications formulated with polysorbate 80
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660816

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
United States, New York
Columbia Presbyterian
New York City, New York, United States, 10032
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Southwest General Health Center
Cleveland, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio State University
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43124
UH-Monarch
Mayfield Heights, Ohio, United States, 44124
UH-Firelands
Sandusky, Ohio, United States, 44870
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Afshin Dowlati, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00660816     History of Changes
Other Study ID Numbers: CASE2507, P30CA043703, CASE2507, CASE-2507-CC350
Study First Received: April 16, 2008
Last Updated: May 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV 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
Docetaxel
Pemetrexed
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014