Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00560573

Purpose

CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R).

Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: CP-751,871 Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase 1, Dose Escalation Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To define the Maximal Tolerated Dose and recommended Phase II dose of CP-751,871 when given in combination with gemcitabine and cisplatin. [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To define the overall safety and tolerability profile of CP-751,871 when given in combination with gemcitabine and cisplatin and when given in combination with pemetrexed and cisplatin. [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
To evaluate the Pharmacokinetics of CP-751,871 in combination with gemcitabine and cisplatin and in combination with pemetrexed and cisplatin and to monitor serum IGF-1 levels as a potential pharmacodynamic response to CP-751,871 treatment. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
To monitor the occurrence of anti-drug antibody response to CP 751,871. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
To monitor for any signs of efficacy of CP-751,871 when given in combination with gemcitabine and cisplatin and when given in combination with pemetrexed and cisplatin. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
To evaluate the effect of Recommended Phase 2 Dose of CP-751,871 on Pharmacokinetics of cisplatin and gemcitabine and on Pharmacokinetics of pemetrexed and cisplatin. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CP-751,871 CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year). Drug: Cisplatin Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles. 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine Drug: Gemcitabine Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles Drug: Pemetrexed Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle

Arms

Assigned Interventions

1: Experimental

Drug: CP-751,871

CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).

Drug: Cisplatin

Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.

75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine

Drug: Gemcitabine

Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles

Drug: Pemetrexed

Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or Stage IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to curative surgery or radiation therapy and an adequate organ function (bone marrow, hepatic, renal, and cardiac) within 14 days prior to enrollment.

Exclusion Criteria:

Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic response modifiers or therapy with any investigational agents.
Patients with known brain metastases, spinal cord compression, uncontrolled superior vein cava syndrome or carcinomatous meningitis.
Patients with gastrointestinal abnormalities including active gastrointestinal bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate haemoglobin level > 7.5%), known HIV or AIDS-related illness, significant active cardiac disease or receiving chronic steroid therapy or concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics should be excluded from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560573

Locations

Belgium
Pfizer Investigational Site
Charleroi, Belgium, 6000
Ireland
Pfizer Investigational Site
Dublin, Ireland, 8
Spain
Pfizer Investigational Site
MADRID, Spain, 28041
Pfizer Investigational Site
SEVILLA, Spain, 41013

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 Inc ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A4021015
Study First Received:	November 15, 2007
Last Updated:	September 5, 2009
ClinicalTrials.gov Identifier:	NCT00560573 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Folate
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Vitamin B9
Carcinoma

Folic Acid
Pemetrexed
Respiratory Tract Diseases
Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Pemetrexed
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009