Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

NCT00735904

Last updated date
Study Location
Pfizer Investigational Site
Torun, , 87-100, Poland
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 (NSCLC) 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 squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy

- Candidate for primary treatment with cisplatin and gemcitabine

- Presence of measurable disease by RECIST

- Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

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


- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.


- One or more lung lesions with cavitation, or any lesion invading or abutting a major
blood vessel as assessed by CT or MRI.


- History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1
week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment


- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment


- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart.


- Untreated brain metastases.


- Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or
other medications known to inhibit platelet function.

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Non-Small-Cell Lung (NSCLC) CarcinomaTrial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
NCT00735904
  1. Torun,
  2. Wodzislaw Sl.,
  3. Cluj-Napoca, Cluj
  4. Bucuresti,
  5. Oradea,
  6. Parktown,
  7. Dnipropetrovsk,
  8. Donetsk,
  9. Kyiv,
  10. Lviv,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
Official Title  ICMJE Phase 2 Trial Of AG-013736 As First-Line Treatment For Patients With Squamous Non-Small Cell Lung Cancer Receiving Treatment With Cisplatin And Gemcitabine
Brief Summary This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung (NSCLC)
Intervention  ICMJE
  • Drug: AG-013736
    AG-013736 5 mg tablets orally, twice daily, until disease progression
    Other Name: axitinib
  • Drug: gemcitabine
    200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles
  • Drug: cisplatin
    1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles
Study Arms  ICMJE Experimental: AG-013736/Cisplatin/Gemcitabine
Interventions:
  • Drug: AG-013736
  • Drug: gemcitabine
  • Drug: cisplatin
Publications * Bondarenko IM, Ingrosso A, Bycott P, Kim S, Cebotaru CL. Phase II study of axitinib with doublet chemotherapy in patients with advanced squamous non-small-cell lung cancer. BMC Cancer. 2015 May 1;15:339. doi: 10.1186/s12885-015-1350-6.

*   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)
38
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
36
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
  • Candidate for primary treatment with cisplatin and gemcitabine
  • Presence of measurable disease by RECIST
  • Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
  • One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
  • History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
  • NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
  • Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
  • Untreated brain metastases.
  • Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.
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 Poland,   Romania,   South Africa,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735904
Other Study ID Numbers  ICMJE A4061038
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 November 2012

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