Trial Outcomes & Findings for A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy (NCT NCT00998166)

NCT ID: NCT00998166

Last Updated: 2024-07-30

Results Overview

PFS defined as the time from the date of the first dose to the first date of disease progression or death.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2024-07-30

Participant Flow

Twelve participants enrolled (signed a consent form). Two participants were screen failures and data was not collected for an additional two participants as the study terminated early, resulting in 8 participants starting the study.

Participant milestones

Measure	Pemetrexed, Cisplatin, Bevacizumab Chemotherapy infusion on Day 1 of a 3-week cycle Pemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour Cisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes Bevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Pemetrexed, Cisplatin, Bevacizumab Chemotherapy infusion on Day 1 of a 3-week cycle Pemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour Cisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes Bevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes
Overall Study Early Study Termination	8

Baseline Characteristics

A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy

Baseline characteristics by cohort

Measure	Pemetrexed, Cisplatin, Bevacizumab n=8 Participants Chemotherapy infusion on Day 1 of a 3-week cycle Pemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour Cisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes Bevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Data was NOT collected due to early study termination and therefore not analyzed.

PFS defined as the time from the date of the first dose to the first date of disease progression or death.

Outcome measures

Outcome data not reported

Adverse Events

Pemetrexed, Cisplatin, Bevacizumab

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pemetrexed, Cisplatin, Bevacizumab n=8 participants at risk Chemotherapy infusion on Day 1 of a 3-week cycle Pemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour Cisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes Bevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes
General disorders Elevated Creatinine	37.5% 3/8
Gastrointestinal disorders Diarrhea	25.0% 2/8
General disorders Back Pain	25.0% 2/8
Gastrointestinal disorders Constipation	37.5% 3/8
General disorders Chest Pain	12.5% 1/8
General disorders Pain	12.5% 1/8
General disorders Headache	12.5% 1/8
Gastrointestinal disorders Nausea	62.5% 5/8
General disorders Fatigue	50.0% 4/8
General disorders Flank Pain	12.5% 1/8
Blood and lymphatic system disorders Thrombotic Microangiopathy	12.5% 1/8
General disorders Abdominal Pain	25.0% 2/8
Immune system disorders Allergic Reaction	12.5% 1/8
Renal and urinary disorders Cystitis	12.5% 1/8
General disorders Pruritis	12.5% 1/8
Cardiac disorders Hypertension	50.0% 4/8
General disorders Hoarseness	12.5% 1/8
Gastrointestinal disorders Anorexia	25.0% 2/8
General disorders Epistaxis	25.0% 2/8
Psychiatric disorders Anxiety	25.0% 2/8
Blood and lymphatic system disorders Anemia	25.0% 2/8
Blood and lymphatic system disorders Hypocalcemia	12.5% 1/8
General disorders Sore throat	12.5% 1/8
Skin and subcutaneous tissue disorders Rash	12.5% 1/8
Gastrointestinal disorders Epigastric Discomfort	12.5% 1/8
General disorders Cough	12.5% 1/8
Blood and lymphatic system disorders Hypokalemia	12.5% 1/8
Blood and lymphatic system disorders Increased Blood Urea Nitrogen	12.5% 1/8
Renal and urinary disorders Urinary Tract Infection	12.5% 1/8
Musculoskeletal and connective tissue disorders Left calf cramps	12.5% 1/8
Ear and labyrinth disorders Tinnitus	25.0% 2/8
General disorders Vasovagal Reaction	12.5% 1/8
General disorders Taste Alteration	12.5% 1/8
Blood and lymphatic system disorders Hyponatremia	12.5% 1/8
Blood and lymphatic system disorders Hypomagnesemia	12.5% 1/8
Blood and lymphatic system disorders Hypoglycemia	12.5% 1/8
Eye disorders Periorbital edema	12.5% 1/8
General disorders Increased Nasal Mucus	12.5% 1/8
Gastrointestinal disorders Vomiting	12.5% 1/8
General disorders Runny Nose	12.5% 1/8
Eye disorders Conjunctivitis	12.5% 1/8
Skin and subcutaneous tissue disorders Skin Tears	12.5% 1/8
General disorders Weight Loss	12.5% 1/8

Additional Information

Mark Stoopler, MD

Columbia University

Phone: 212-305-8230

Email: mbs5@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place