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Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Study NCT00460603   Information provided by Pfizer
First Received: April 13, 2007   Last Updated: March 6, 2010   History of Changes

April 13, 2007
March 6, 2010
January 2006
April 2011   (final data collection date for primary outcome measure)
Phase 2 portion: objective response rate [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]
Estimate the objective response rate in previously untreated patients with advanced colorectal cancer treated with AG013736/FOLFOX/bevacizumab vs. AG013736/FOLFOX vs bevacizumab/FOLFOX
Complete list of historical versions of study NCT00460603 on ClinicalTrials.gov Archive Site
  • Plasma pharmacokinetics of AG-013736, oxaliplatin, irinotecan and 5-FU, including AUC, Cmax, Cmin, clearance, and t1/2 (Phase 1 portion only) [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]
  • Safety profile of treatments based on physical examinations, laboratory tests, and assessment of adverse events [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]
  • Tumor response and disease progression according to RECIST. Response rate (including complete and partial responses), duration of response and progression-free survival will be determined in the Phase 2 portion of the study [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Until Death ] [ Designated as safety issue: No ]
  • Patient-reported outcomes (PROs) of colorectal cancer-specific symptoms [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]
  • Determine maximum tolerated doses of bevaxizumab, AG013736, FOLFOX (5FU, Oxaliplatin, leucovorin) given to patients with solid tumors (Ph 1)
  • Determine safety of AG013736, FOLFIRI (5FU, irinotecan, leucovorin), with or without bevacizumab (Ph 1)
  • Evaluate potential pharmacokinetic (PK) interactions among bevacizumab, AG013736 and FOLFOX (Ph 1)
  • Evaluate potential PK interactiosn among bevacizumab, AG013736, and FOLFIRI (Ph 1)
  • Evaluate the adverse event profile and dose-limiting toxicities for each combination
  • Estimate the response rate, duration of response, progression-free survival, and survival in each arm (Ph 2)
  • Evaluate patient-reported outcomes of colorectal cancer-specific symptoms in each arm (Ph 2)
 
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion

To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.

 
Phase I, Phase II
Interventional
Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment
Colorectal Neoplasms
  • Drug: bevacizumab
    bevacizumab 5 mg/kg every 2 weeks
  • Drug: AG-013726
    AG-013726 5 mg bid every 2 weeks
  • Drug: AG-013736 (axitinib)
    AG-013736 5 mg bid starting dose
  • B: Active Comparator
    bevacizumab 5 mg/kg every 2 weeks + FOLFOX
    Intervention: Drug: bevacizumab
  • C: Experimental
    AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX
    Intervention: Drug: AG-013726
  • A: Experimental
    AG-013736 5 mg bid starting dose + FOLFOX
    Intervention: Drug: AG-013736 (axitinib)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
123
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
  • (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
  • Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was > 12 months prior to enrollment,
  • Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.

Exclusion Criteria:

  • Prior system therapy for advanced CRC (Ph 2 portion only)
  • Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
  • Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
  • Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed > 2 weeks of enrollment and be fully recovered from any procedure.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com
United States
 
NCT00460603
Director, Clinical Trial Disclosure Group, Pfizer Inc
A4061020
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

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