Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

NCT00147537 | Completed Phase 1 Results

• 1 other identifier: A4021002
• Study Type: interventional
• Target: 282
• Locations: 4 countries
• Sites: 31

Brief Summary

Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib. Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

non-small cell lung cancer; chemotherapy; figitumumab; insulin-like growth 1 factor receptor; IGF-IR; monoclonal antibody

Outcome Measures

Primary Outcomes (4)

• Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b

  The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.

  Start of treatment (baseline) up to the end of Cycle 1 (Day 21)

• Recommended Phase 2 Dose (RP2D): Phase 1b

  Start of treatment (baseline) up to the end of Cycle 1 (Day 21)

• Objective Response Rate: Phase 2

  Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

  Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization

• Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2

  Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

  Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization

Secondary Outcomes (29)

• Objective Response Rate: Phase 1b

  Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization

• Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b

  Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)

• Number of Circulating Endothelial Cells (CECs): Phase 1b

  Day 1 pre-dose and Days 15 to 21 of Cycle 4

• Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b

  Day 1 pre-dose and Days 15 to 21 of Cycle 4

• Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b

  Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)

Study Arms (2)

Phase 2 (Arms A & B)

EXPERIMENTAL

CP-751,871 + paclitaxel + carboplatin

Drug: CP-751,871; Drug: paclitaxel; Drug: carboplatin

Phase 1b

EXPERIMENTAL

1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin 2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib

Drug: CP-751,871; Drug: paclitaxel; Drug: carboplatin; Drug: erlotinib

Interventions

CP-751,871 DRUG

Phase 2 Arm A: CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

Phase 2 (Arms A & B)

paclitaxel DRUG

Phase 2 Arm A: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles Phase 2 Arm B: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Phase 2 (Arms A & B)

carboplatin DRUG

Phase 2 Arm A: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles Phase 2 Arm B: Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 2 (Arms A & B)

erlotinib DRUG

Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced/metastatic lung cancer

You may not qualify if:

• Previous treatment with chemotherapy
• Uncontrolled diabetes
• History/active cardiovascular disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Pfizer Investigational Site

Tucson, Arizona, 85719, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85724-5024, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85724, United States

Location

Pfizer Investigational Site

Greenbrae, California, 94904, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32224, United States

Location

Pfizer Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40207, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40241, United States

Location

Pfizer Investigational Site

Shelbyville, Kentucky, 40065, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21204, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

Corinth, Mississippi, 38834, United States

Location

Pfizer Investigational Site

Southaven, Mississippi, 38671, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10461, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10467, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38104, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Orbassano (TO), 10043, Italy

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

figitumumab; Paclitaxel; Carboplatin; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: February 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 30, 2013
• Results First Posted: April 24, 2013

Record last verified: 2013-10

Locations

ES (3); CA (1); IT (1); US (26)