A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00977561 |
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Recruitment Status :
Terminated
(See termination reason in detailed description.)
First Posted : September 15, 2009
Results First Posted : February 25, 2013
Last Update Posted : February 25, 2013
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small Cell Lung Carcinoma | Drug: figitumumab Drug: Cisplatin (Or Carboplatin) Drug: Etoposide | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | October 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
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Drug: figitumumab
Figitumumab (20 mg/kg) Drug: Cisplatin (Or Carboplatin) Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 Drug: Etoposide Etoposide (100 mg/m2 IV on Days 1, 2 and 3) |
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Active Comparator: Arm B
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
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Drug: Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 Drug: Etoposide Etoposide (100 mg/m2 IV on Days 1, 2 and 3) |
Primary Outcome Measures :
- Progression-Free Survival (PFS) [ Time Frame: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression ]Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
Secondary Outcome Measures :
- Number of Participants With Objective Response [ Time Frame: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression ]Number 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 Tumors (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.
- Overall Survival (OS) [ Time Frame: Every 3 months until death or 12 months from the date the last participant was randomized ]Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to follow-up (90 days post dose) ]AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.
- Maximum Observed Plasma Concentration (Cmax) of Figitumumab [ Time Frame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose ]
- Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab [ Time Frame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide [ Time Frame: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion ]Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Maximum Observed Plasma Concentration (Cmax) of Etoposide [ Time Frame: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion ]
- Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab [ Time Frame: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose ]Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
- Cancer Dyspnea Scale (CDS) Score [ Time Frame: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression ]The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").
- Numeric Rating Scale (NRS) Score [ Time Frame: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression ]The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.
- Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway [ Time Frame: Baseline prior to dosing ]
- Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers [ Time Frame: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose) ]
- Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs [ Time Frame: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose) ]Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml
Exclusion Criteria:
- Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
- HbA1c > or = 5.7%
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977561
Locations
Show 51 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00977561 |
| Other Study ID Numbers: |
A4021032 |
| First Posted: | September 15, 2009 Key Record Dates |
| Results First Posted: | February 25, 2013 |
| Last Update Posted: | February 25, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Pfizer:
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Small Cell Lung Cancer Extensive stage disease SCLC IGF-1R inhibitor |
Additional relevant MeSH terms:
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Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Cisplatin Carboplatin Etoposide Etoposide phosphate Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |