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

• ClinicalTrials.gov Identifier: NCT00735904
• Recruitment Status: Completed
• First Posted: August 15, 2008
• Results First Posted: January 3, 2013
• Last Update Posted: January 3, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 13, 2008
• First Posted Date: August 15, 2008
• Results First Submitted Date: November 30, 2012
• Results First Posted Date: January 3, 2013
• Last Update Posted Date: January 3, 2013
• Study Start Date: December 2008
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2012)

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) ]

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.

• Original Primary Outcome Measures (submitted: August 13, 2008): Objective Response Rate [ Time Frame: 2.5 years ]

Current Secondary Outcome Measures (submitted: November 30, 2012)

• Overall Survival (OS) [ Time Frame: Baseline until death or assessed every 2 months (up to 28 days after the last dose) ]
  Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
• Progression Free Survival (PFS) [ Time Frame: Baseline, assessed every 2 months (up to 28 days after the last dose) ]
  Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
• Duration of Response (DR) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) ]
  Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Original Secondary Outcome Measures (submitted: August 13, 2008)

• Overall Survival [ Time Frame: 2.5 years ]
• Progression-Free Survival [ Time Frame: 2.5 years ]
• Duration of Response [ Time Frame: 2.5 years ]
• Overall Safety Profile [ Time Frame: 2.5 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung (NSCLC)

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2011): 38
• Original Estimated Enrollment (submitted: August 13, 2008): 36
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland, Romania, South Africa, Ukraine

Administrative Information

• NCT Number: NCT00735904
• Other Study ID Numbers: A4061038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2012