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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35805 United States
Contact
1-800-718-1021
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.

NCT00768755
Pfizer
Completed
Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

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Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer
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
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).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • 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
  • 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
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.
 
Completed
180
March 2012
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Japan,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
South Africa
 
NCT00768755
A4061039
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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