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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Torun, , 87-100 Poland
Contact
1-800-718-1021
ClinicalTrials.gov_Inqu[email protected]
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.

NCT00735904
Pfizer
Completed
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

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Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
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
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung (NSCLC)
  • 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
Experimental: AG-013736/Cisplatin/Gemcitabine
Interventions:
  • Drug: AG-013736
  • Drug: gemcitabine
  • Drug: cisplatin
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.
 
Completed
38
November 2011
November 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Romania,   South Africa,   Ukraine
 
 
NCT00735904
A4061038
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

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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1-800-718-1021

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[email protected]



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