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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose-limiting Toxicities (DLT)

Outcome Description:

Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment

Outcome Time Frame:

Start of treatment up to end of Cycle 1, Day 21

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021015

NCT ID:

NCT00560573

Start Date:

November 2007

Completion Date:

March 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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