A Phase 2 interventional study of cetuximab and paclitaxel in Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer and Bronchoalveolar Cell Lung Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-14.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells. This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab works in treating patients with advanced non-small cell lung cancer
PRIMARY OBJECTIVES:
I. To evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with the combination of carboplatin, paclitaxel, cetuximab and bevacizumab followed by therapy with cetuximab and bevacizumab.
SECONDARY OBJECTIVES:
I. To evaluate progression-free and overall survival, response rate (confirmed plus unconfirmed, complete plus partial), and frequency and severity of non-hemorrhage toxicities in this group of patients treated with this regimen.
II. To perform molecular correlative studies on patient tissue to investigate in an exploratory manner potential predictors of efficacy.
OUTLINE: This is a multicenter study.
INDUCTION THERAPY: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
INDUCTION THERAPY: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Biological: cetuximab · Drug: paclitaxel · Biological: bevacizumab
Given IV
Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Given IV
Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.
All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.
Time frame: Every week until removed from protocol therapy, up to 3 years.
Progression-Free Survival
From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Time frame: Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.
Overall Survival
From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.
Time frame: Once a week, up to 3 years.
Response Rate
Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a \>= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.
Time frame: Every 6 weeks while on protocol treatment, up to 3 years.
| Milestone | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Started | 110 |
| Completed | 0 |
| Not completed | 110 |
| Withdrew: Ineligible | 5 |
| Withdrew: Refused treatment | 3 |
| Withdrew: Lack of efficacy | 63 |
| Withdrew: Adverse event | 26 |
| Withdrew: Death | 4 |
| Withdrew: Other | 9 |
All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.
| percentage of participants | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment. | 2 (0 to 7) |
From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
| Months | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Progression-Free Survival | 7 (6 to 8) |
From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.
| months | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Overall Survival | 15 (11 to 21) |
Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a \>= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.
| percentage of participants | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Response Rate | 56 (44 to 65) |
Collected over Weekly while on protocol treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab | — | 51/102 (50%) | 101/102 (99%) |
| Event | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Neutrophils/granulocytes (ANC/AGC)Investigations | 16/102 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 9/102 |
| DehydrationMetabolism and nutrition disorders | 7/102 |
| Thrombosis/thrombus/embolismVascular disorders | 7/102 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 6/102 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/102 |
| NauseaGastrointestinal disorders | 5/102 |
| Inf (clin/microbio) w/Gr 3-4 neuts - LungInfections and infestations | 4/102 |
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 4/102 |
| Inf w/normal ANC or Gr 1-2 neutrophils - LungInfections and infestations | 3/102 |
| Event | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Fatigue (asthenia, lethargy, malaise)General disorders | 88/102 |
| Rash: acne/acneiformSkin and subcutaneous tissue disorders | 78/102 |
| Neuropathy: sensoryNervous system disorders | 76/102 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 62/102 |
| HemoglobinBlood and lymphatic system disorders | 58/102 |
| ConstipationGastrointestinal disorders | 57/102 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 56/102 |
| NauseaGastrointestinal disorders | 53/102 |
| Leukocytes (total WBC)Investigations | 52/102 |
| Magnesium, serum-low (hypomagnesemia)Metabolism and nutrition disorders | 50/102 |
| Age, Continuous(years) | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Median | 64 (42 to 78) |
| Sex: Female, Male(Participants) | Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab |
|---|---|
| Female | 50 |
| Male | 52 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)