A Phase 2 interventional study of figitumumab and Cisplatin (Or Carboplatin) in Small Cell Lung Carcinoma, sponsored by Pfizer. Terminated at 51 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's enrollment of 9 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Figitumumab (CP-751,871) Plus Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle
Drug: figitumumab · Drug: Cisplatin (Or Carboplatin) · Drug: Etoposide
Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle
Drug: Cisplatin (Or Carboplatin) · Drug: Etoposide
Figitumumab (20 mg/kg)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Progression-Free Survival (PFS)
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) = \[event (progression or death) date or censor date - date of randomization + 1\].
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
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.
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
Overall Survival (OS)
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) = \[death date (last known alive date) - date of randomization +1\].
Time frame: Every 3 months until death or 12 months from the date the last participant was randomized
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to follow-up (90 days post dose)
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
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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
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
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) 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
Cancer Dyspnea Scale (CDS) Score
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").
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
Numeric Rating Scale (NRS) Score
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.
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
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
Pre-treatment and post-treatment counts of total and IGF-IR-positive 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)
| Milestone | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide |
|---|---|---|
| Started | 5 | 4 |
| Completed | 0 | 0 |
| Not completed | 5 | 4 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Study terminated | 0 | 2 |
| Withdrew: Other | 2 | 0 |
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) = \[event (progression or death) date or censor date - date of randomization + 1\].
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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) = \[death date (last known alive date) - date of randomization +1\].
No measurements were reported for this outcome.
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.
| participants | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide |
|---|---|---|
| Adverse Events | 5 | 4 |
| Serious Adverse Events | 4 | 2 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
No measurements were reported for this outcome.
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").
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Figitumumab + Cisplatin or Carboplatin + Etoposide | — | 4/5 (80%) | 5/5 (100%) |
| Cisplatin or Carboplatin + Etoposide | — | 2/4 (50%) | 4/4 (100%) |
| Event | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/5 | 1/4 |
| Disease progressionGeneral disorders | 1/5 | 1/4 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/5 | 0/4 |
| Myocardial infarctionCardiac disorders | 1/5 | 0/4 |
| DiarrhoeaGastrointestinal disorders | 1/5 | 0/4 |
| VomitingGastrointestinal disorders | 1/5 | 0/4 |
| DehydrationMetabolism and nutrition disorders | 1/5 | 0/4 |
| Psychotic disorderPsychiatric disorders | 1/5 | 0/4 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/5 | 0/4 |
| Event | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 4/5 | 4/4 |
| NauseaGastrointestinal disorders | 3/5 | 4/4 |
| Back painMusculoskeletal and connective tissue disorders | 0/5 | 3/4 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/5 | 2/4 |
| AnaemiaBlood and lymphatic system disorders | 0/5 | 2/4 |
| ConstipationGastrointestinal disorders | 1/5 | 2/4 |
| VomitingGastrointestinal disorders | 1/5 | 2/4 |
| AstheniaGeneral disorders | 1/5 | 2/4 |
| CandidiasisInfections and infestations | 0/5 | 2/4 |
| DehydrationMetabolism and nutrition disorders | 0/5 | 2/4 |
| Age Continuous(years) | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide | Total |
|---|---|---|---|
| Mean | 60.4 ± 4.4 | 53.8 ± 11.0 | 57.4 ± 8.2 |
| Sex: Female, Male(Participants) | Figitumumab + Cisplatin or Carboplatin + Etoposide | Cisplatin or Carboplatin + Etoposide | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 0 | 3 | 3 |
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Figitumumab