Trial Outcomes & Findings for Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC (NCT NCT01042288)

NCT ID: NCT01042288

Last Updated: 2016-05-11

Results Overview

Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2016-05-11

Participant Flow

One patient signed the consent but had a stroke prior to the pre-treatment and Cycle 1-Day 1 visits.

Participant milestones

Measure	Carboplatin/Pemetrexed/Panitumumab Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Overall Study STARTED	69
Overall Study Maintenance	27
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	69

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC

Baseline characteristics by cohort

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: All enrolled and treated patients

Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.

Outcome measures

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Median Time to Progression (TTP)	6.11 months Interval 5.42 to 9.07

SECONDARY outcome

Timeframe: Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months

Population: All enrolled and treated patients

Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.

Outcome measures

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Median Progression-free Survival (PFS)	5.75 months Interval 4.99 to 8.05

SECONDARY outcome

Timeframe: 18 months

Population: All enrolled and treated patients

Defined as the time between Day 1-Cycle 1 to the date of death from any cause.

Outcome measures

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Median Overall Survival (OS)	17.02 months Interval 11.33 to 19.68

SECONDARY outcome

Timeframe: Projected 18 months

Population: All patients evaluated for response

Outcome measures

Measure	Carboplatin/Pemetrexed/Panitumumab n=60 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Objective Response Rate	53 percentage of evaluated participants

SECONDARY outcome

Timeframe: Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter

Assessed using NCI CTCAE v4.0

Outcome measures

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 Participants Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Frequency of Adverse Events and Severity as a Measure of Toxicity Vomiting	15 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Dehydration	13 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Rash	55 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Nausea	39 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Fatigue	33 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Hypomagnesemia	30 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Neutrophil Count Decreased	30 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Platelet Count Decreased	29 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Anemia	28 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Mucositis	23 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Dry Skin	22 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Anorexia	19 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Diarrhea	19 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Constipation	17 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity White Blood Cell Decreased	16 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Pruritus	15 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Dysgeusia	12 participants
Frequency of Adverse Events and Severity as a Measure of Toxicity Alopecia	11 participants

Adverse Events

Carboplatin/Pemetrexed/Panitumumab

Serious events: 24 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 participants at risk Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Gastrointestinal disorders Abdominal pain	1.4% 1/69
Blood and lymphatic system disorders Anemia	2.9% 2/69
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/69
Infections and infestations Bladder infection	1.4% 1/69
Cardiac disorders Cardiac disorders - Other, bradycardia	1.4% 1/69
Psychiatric disorders Confusion	1.4% 1/69
Metabolism and nutrition disorders Dehydration	4.3% 3/69
Gastrointestinal disorders Diarrhea	2.9% 2/69
Gastrointestinal disorders Duodenal Ulcer	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 3/69
General disorders Fatigue	1.4% 1/69
Gastrointestinal disorders Gastrointestinal disorders - Other, small bowel obstruction	1.4% 1/69
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.9% 2/69
Renal and urinary disorders Hematuria	1.4% 1/69
Metabolism and nutrition disorders Hypernatremia	1.4% 1/69
Metabolism and nutrition disorders Hypokalemia	1.4% 1/69
Gastrointestinal disorders Ileus	1.4% 1/69
Infections and infestations Infections and infestations - Other, bacteremia	1.4% 1/69
Infections and infestations Infections and infestations - Other, clostridium difficile infection	1.4% 1/69
Infections and infestations Infections and infestations - Other, Staphylococcus	1.4% 1/69
Investigations Investigations - Other, pancytopenia	1.4% 1/69
Gastrointestinal disorders Mucositis	2.9% 2/69
Gastrointestinal disorders Nausea	1.4% 1/69
Investigations Neutrophil count decreased	1.4% 1/69
General disorders Non-cardiac chest pain	2.9% 2/69
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/69
Respiratory, thoracic and mediastinal disorders pleural effusion	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation	1.4% 1/69
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, respiratory distress	1.4% 1/69
Nervous system disorders Seizure	2.9% 2/69
Nervous system disorders stroke	1.4% 1/69
Nervous system disorders Syncope	1.4% 1/69
Vascular disorders Thromboembolic event	2.9% 2/69
Infections and infestations Urinary Tract Infection	2.9% 2/69
Renal and urinary disorders Urinary tract pain	1.4% 1/69
Gastrointestinal disorders Vomiting	1.4% 1/69
Investigations White blood cell decreased	1.4% 1/69

Other adverse events

Measure	Carboplatin/Pemetrexed/Panitumumab n=69 participants at risk Systemic Therapy Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
Skin and subcutaneous tissue disorders rash	79.7% 55/69
Gastrointestinal disorders Nausea	66.7% 46/69
General disorders Fatigue	62.3% 43/69
Metabolism and nutrition disorders Hypomagnesemia	52.2% 36/69
Investigations platelet count decreased	50.7% 35/69
Blood and lymphatic system disorders Anemia	47.8% 33/69
Investigations neutrophil count decreased	47.8% 33/69
Gastrointestinal disorders Constipation	40.6% 28/69
Gastrointestinal disorders diarrhea	36.2% 25/69
Gastrointestinal disorders Mucositis	36.2% 25/69
Respiratory, thoracic and mediastinal disorders Dyspnea	34.8% 24/69
Skin and subcutaneous tissue disorders Dry Skin	31.9% 22/69
Metabolism and nutrition disorders Anorexia	29.0% 20/69
Metabolism and nutrition disorders Hyperglycemia	29.0% 20/69
Investigations white blood cell decreased	29.0% 20/69
Skin and subcutaneous tissue disorders Pruritus	27.5% 19/69
Gastrointestinal disorders Vomiting	27.5% 19/69
Metabolism and nutrition disorders Dehydration	24.6% 17/69
Respiratory, thoracic and mediastinal disorders Cough	21.7% 15/69
Metabolism and nutrition disorders Hypokalemia	21.7% 15/69
Metabolism and nutrition disorders Hypoalbuminemia	20.3% 14/69
Investigations Weight Loss	20.3% 14/69
Skin and subcutaneous tissue disorders Alopecia	18.8% 13/69
Nervous system disorders Dysgeusia	17.4% 12/69
Gastrointestinal disorders abdominal pain	15.9% 11/69
General disorders Edema limbs	13.0% 9/69
Metabolism and nutrition disorders Hypocalcemia	13.0% 9/69
Skin and subcutaneous tissue disorders rash acneiform	13.0% 9/69
Investigations alkaline phosphatase increased	11.6% 8/69
Nervous system disorders dizziness	11.6% 8/69
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.6% 8/69
Nervous system disorders headache	11.6% 8/69
Metabolism and nutrition disorders Hyponatremia	11.6% 8/69
Psychiatric disorders Insomnia	11.6% 8/69
General disorders Fever	10.1% 7/69
Metabolism and nutrition disorders Hyperkalemia	10.1% 7/69
Respiratory, thoracic and mediastinal disorders nasal congestion	10.1% 7/69
General disorders Pain	10.1% 7/69
Investigations Alanine aminotransferase increased	8.7% 6/69
Musculoskeletal and connective tissue disorders Back pain	8.7% 6/69
General disorders Chills	8.7% 6/69
Investigations creatinine increased	8.7% 6/69
Gastrointestinal disorders dyspepsia	8.7% 6/69
Investigations Investigations - Other, blood chloride decreased	8.7% 6/69
Musculoskeletal and connective tissue disorders Pain in Extremity	8.7% 6/69
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, erythema	8.7% 6/69
Psychiatric disorders Anxiety	7.2% 5/69
Eye disorders Dry eye	7.2% 5/69
Respiratory, thoracic and mediastinal disorders epistaxis	7.2% 5/69
Gastrointestinal disorders Gastroesophageal reflux disease	7.2% 5/69
General disorders Infusion Related Reaction	7.2% 5/69
Investigations Investigations - Other, blood urea nitrogen decreased	7.2% 5/69
Respiratory, thoracic and mediastinal disorders Sore throat	7.2% 5/69
Infections and infestations Urinary Tract Infection	7.2% 5/69
Eye disorders watering eyes	7.2% 5/69
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 4/69
Investigations Aspartate aminotransferase increased	5.8% 4/69
Eye disorders Blurred vision	5.8% 4/69
Injury, poisoning and procedural complications Bruising	5.8% 4/69
Eye disorders Eye pain	5.8% 4/69
Metabolism and nutrition disorders Hypermagnesemia	5.8% 4/69
Vascular disorders Hypotension	5.8% 4/69
Investigations Investigations - Other, blood protein decreased	5.8% 4/69
Investigations Investigations - Other, creatinine decreased	5.8% 4/69
Investigations Investigations - Other, LDH increased	5.8% 4/69
General disorders Non-cardiac chest pain	5.8% 4/69
Nervous system disorders peripheral sensory neuropathy	5.8% 4/69
Infections and infestations sinusitis	5.8% 4/69
Infections and infestations Skin infection	5.8% 4/69
Vascular disorders Thromboembolic event	5.8% 4/69
Infections and infestations Vaginal infection	5.8% 4/69

Additional Information

John D Hainsworth, MD

Sarah Cannon Research Institute

Phone: 1-877-691-7274

Email: asksarah@scresearch.net

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
• Publication restrictions are in place

Restriction type: OTHER