Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors - Full Text View

Purpose

This is a dose-finding study; therefore, there is no hypothesis testing

Condition	Intervention	Phase
Neoplasms	Drug: Paclitaxel + Carboplatin + CP-870,893	Phase I

MedlinePlus related topics:

Cancer

Drug Information available for:

Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Official Title:	A Phase 1 Study Of CP- 870,893 In Combination With Paclitaxel And Carboplatin In Patients With Metastatic Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

Adverse events [ Time Frame: 1 cycle for each patient enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Maximal plasma concentration and area under the curve from zero to the last timepoint (Cmax and AUClast) [ Time Frame: 12 months (max) ] [ Designated as safety issue: Yes ]
Change in cytokine concentrations of tumor necrosis factor alpha and interleukin 6 (TNF alpha, IL 6) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Total and neutralizing Human Antihuman Antibody (HAHA) titer [ Time Frame: 12 months (max) ] [ Designated as safety issue: Yes ]
Changes in bone marrow derived cells (B cell) surface markers [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Tumor response of Partial Response (PR) and Complete Response CR) [ Time Frame: 12 months (max) ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
Schedule A Schedule A (CP-870,893 administration schedule)	Drug: Paclitaxel + Carboplatin + CP-870,893 Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
Schedule B Schedule B (CP-870,893 administration schedule)	Drug: Paclitaxel + Carboplatin + CP-870,893 Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Eligibility

Criteria

Inclusion Criteria:

Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate;
Patients >18 years of age;
Good performance status;
Adequate bone marrow and organ function

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607048

Contacts


Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


United States, Pennsylvania
	Pfizer Investigational Site	Recruiting
	Philadelphia, Pennsylvania, United States, 19104

United States, Texas
	Pfizer Investigational Site	Recruiting
	San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5021004
First Received:	January 22, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00607048
Health Authority:	United States: Food and Drug Administration