Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00460603

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: bevacizumab Drug: AG-013726 Drug: AG-013736 (axitinib)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab Axitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Phase 2 portion: objective response rate [ Time Frame: Baselines to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	123
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B bevacizumab 5 mg/kg every 2 weeks + FOLFOX	Drug: bevacizumab bevacizumab 5 mg/kg every 2 weeks
Experimental: C AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX	Drug: AG-013726 AG-013726 5 mg bid every 2 weeks
Experimental: A AG-013736 5 mg bid starting dose + FOLFOX	Drug: AG-013736 (axitinib) AG-013736 5 mg bid starting dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460603

Show 107 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00460603 History of Changes
Other Study ID Numbers:	A4061020
Study First Received:	April 13, 2007
Last Updated:	January 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

GI neoplasms (phase 1)

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Angiogenesis Inhibitors
Bevacizumab
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012