Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

NCT00768755

Last updated date
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35805, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer

- Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.

- Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.

- Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.

- Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any histological/cytological evidence of predominantly squamous NSCLC.


- Small cell or carcinoid lung cancer patients are also ineligible.


- NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma,
large cell or bronchioalveolar).


- Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or
recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in
conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose
of chemotherapy was completed 12 months or more prior to randomization).


- Prior treatment with a VEGF or VEGFR inhibitor.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer
Official Title  ICMJE Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer
Brief Summary AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: axitinib
    5mg BID po up to max 10mg BID po
    Other Name: AG-013736
  • Drug: axitinib
    5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
    Other Name: AG-013736
  • Drug: chemotherapy
    Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
    Other Name: alimta
  • Drug: axitinib
    5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy
Study Arms  ICMJE
  • Experimental: I
    Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
    Intervention: Drug: axitinib
  • Experimental: II
    Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
    Intervention: Drug: axitinib
  • Active Comparator: III
    pemetrexed and cisplatin
    Intervention: Drug: chemotherapy
  • Experimental: IV
    Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance
    Intervention: Drug: axitinib
  • Active Comparator: V
    pemetrexed and cisplatin
    Intervention: Drug: chemotherapy
Publications * Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2011)
180
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)
160
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
  • Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
  • Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
  • Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
  • Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria:

  • Any histological/cytological evidence of predominantly squamous NSCLC.
  • Small cell or carcinoid lung cancer patients are also ineligible.
  • NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
  • Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
  • Prior treatment with a VEGF or VEGFR inhibitor.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Japan,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries South Africa
 
Administrative Information
NCT Number  ICMJE NCT00768755
Other Study ID Numbers  ICMJE A4061039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP