Trial Outcomes & Findings for Study of Pemetrexed and Bevacizumab in Patients With Head and Neck Cancer (NCT NCT00222729)

NCT ID: NCT00222729

Last Updated: 2016-02-15

Results Overview

TTP was calculated from treatment initiation to disease progression or last follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: Up to 36 months
• Results posted on: 2016-02-15

Participant Flow

Participant milestones

Measure	Pemetrexed + Bevacizumab Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Pemetrexed + Bevacizumab Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Overall Study Adverse Event	3

Baseline Characteristics

Study of Pemetrexed and Bevacizumab in Patients With Head and Neck Cancer

Baseline characteristics by cohort

Measure	Pemetrexed + Bevacizumab n=40 Participants Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2

TTP was calculated from treatment initiation to disease progression or last follow-up.

Outcome measures

Measure	Pemetrexed + Bevacizumab n=37 Participants Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Time-to-progression (TTP)	5 months Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2

Outcome measures

Measure	Pemetrexed + Bevacizumab n=37 Participants Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Objective Response Rate (ORR)	30 percentage Interval 17.0 to 42.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg

Outcome measures

Measure	Pemetrexed + Bevacizumab n=37 Participants Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Disease Control Rate (DCR)	86 percentage Interval 77.0 to 96.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg

Outcome measures

Measure	Pemetrexed + Bevacizumab n=37 Participants Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Overall Survival (OS)	11.3 months Interval 8.7 to 16.8

Adverse Events

Pemetrexed + Bevacizumab

Serious events: 28 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pemetrexed + Bevacizumab n=40 participants at risk Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
Blood and lymphatic system disorders Anemia	5.0% 2/40
Metabolism and nutrition disorders Anorexia	2.5% 1/40
Metabolism and nutrition disorders AST increase	2.5% 1/40
Blood and lymphatic system disorders Bleeding	15.0% 6/40
Blood and lymphatic system disorders Edema	2.5% 1/40
General disorders Fatigue	5.0% 2/40
Vascular disorders Hypertension	2.5% 1/40
Metabolism and nutrition disorders Hypokalemia	5.0% 2/40
Metabolism and nutrition disorders Hyponatremia	5.0% 2/40
Infections and infestations Infection-other	12.5% 5/40
Gastrointestinal disorders Mucositis	2.5% 1/40
Blood and lymphatic system disorders Neutropenia	10.0% 4/40

Other adverse events

Measure	Pemetrexed + Bevacizumab n=40 participants at risk Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
General disorders Constitutional Symptoms - Other	5.0% 2/40
General disorders Constitutional Symptoms-Other	2.5% 1/40
Gastrointestinal disorders Dehydration	2.5% 1/40
Gastrointestinal disorders Dysphagia (difficulty swallowing)	25.0% 10/40
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	2.5% 1/40
Gastrointestinal disorders Dysphagia-pharyngeal related to radiation	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	22.5% 9/40
General disorders Fatigue (asthenia, lethargy, malaise)	50.0% 20/40
General disorders Fatigue (lethargy, malaise, asthenia)	7.5% 3/40
Gastrointestinal disorders Fistula, GI, Oral cavity	2.5% 1/40
Infections and infestations Fistula, GI, Oral cavity	2.5% 1/40
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	32.5% 13/40
Blood and lymphatic system disorders Hemoglobin	32.5% 13/40
Blood and lymphatic system disorders Hemorrhage, GI, Oral cavity	5.0% 2/40
Blood and lymphatic system disorders Hemorrhage/Bleeding - Other	7.5% 3/40
Blood and lymphatic system disorders Hemorrhage-Other	2.5% 1/40
Vascular disorders Hypertension	5.0% 2/40
Metabolism and nutrition disorders Hyponatremia	2.5% 1/40
Infections and infestations Infection - Other	15.0% 6/40
Infections and infestations Infection without neutropenia	2.5% 1/40
Blood and lymphatic system disorders Leukocytes (total WBC)	17.5% 7/40
Blood and lymphatic system disorders Lymphopenia	25.0% 10/40
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), Oral cavity	10.0% 4/40
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized	2.5% 1/40
Gastrointestinal disorders Nausea	17.5% 7/40
Nervous system disorders Neuropathy: motor	2.5% 1/40
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	12.5% 5/40
Respiratory, thoracic and mediastinal disorders Obstruction/stenosis of airway, Trachea	2.5% 1/40
General disorders Pain, Head/headache	12.5% 5/40
General disorders Pain-Other	7.5% 3/40
Gastrointestinal disorders Perforation, GI, Colon	2.5% 1/40
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	2.5% 1/40
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	7.5% 3/40
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	2.5% 1/40
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	5.0% 2/40
Nervous system disorders Seizure	2.5% 1/40
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	2.5% 1/40
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	25.0% 10/40
Gastrointestinal disorders Stricture/stenosis (including anastomotic), GI, Esophagus	2.5% 1/40
Nervous system disorders Syncope (fainting)	2.5% 1/40
Vascular disorders Vasovagal episode	2.5% 1/40
Gastrointestinal disorders Vomiting	5.0% 2/40
General disorders Weight loss	17.5% 7/40

Additional Information

Rita Johnson, Associate Director of Clinical Research Services

UPMC Cancer Centers

Phone: 412-647-8571

Email: johnsonr1@upmc.edu

Results disclosure agreements

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