Trial Outcomes & Findings for Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC (NCT NCT00519831)

NCT ID: NCT00519831

Last Updated: 2017-06-09

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Baseline, after cycle 2, within 2 weeks of completing cycle 4

Results posted on

2017-06-09

Participant Flow

18 patients were enrolled, 2 patients were consented but not enrolled. 1 patient withdrew and 1 patient was taken off the study due to decline in performance status.

Participant milestones

Participant milestones
Measure	Vinflunine + Cetuximab Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vinflunine + Cetuximab Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Overall Study Adverse Event	3

Baseline Characteristics

Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vinflunine + Cetuximab n=16 Participants Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Age, Continuous	60.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Number of Participants who had a score of 0-1 in the The Eastern Cooperative Oncology Group (ECOG)	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, after cycle 2, within 2 weeks of completing cycle 4

Outcome measures

Outcome measures
Measure	Vinflunine + Cetuximab n=13 Participants Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).	3 Participants

SECONDARY outcome

Timeframe: After cycle 4

Population: Data not collected due to early study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 30 days

Population: Data not collected due to early study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after cycle 2, within 2 weeks of completing cycle 4

Population: Data not collected due to early study termination.

Outcome measures

Outcome data not reported

Adverse Events

Vinflunine + Cetuximab

Serious events: 8 serious events

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Vinflunine + Cetuximab n=16 participants at risk Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Infections and infestations Infection - Lung	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Investigations Neutrophils/granulocytes (ANC/AGC)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Constipation	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Nausea	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.

Other adverse events

Other adverse events
Measure	Vinflunine + Cetuximab n=16 participants at risk Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator. cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly vinflunine: Vinflunine 320 mg/m² every 21 days
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Constipation	31.2% 5/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 3/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Investigations Creatinine	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Eye disorders Dry eye syndrome	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Dry skin	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	18.8% 3/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
General disorders Fatigue (asthenia, lethargy, malaise)	25.0% 4/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	18.8% 3/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Investigations Leukocytes (total WBC)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Metabolism and nutrition disorders Metabolic/Laboratory - Other (Specify, __)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Psychiatric disorders Mood alteration - Anxiety	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Nail changes	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Nausea	25.0% 4/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Investigations Neutrophils/granulocytes (ANC/AGC)	68.8% 11/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Eye disorders Ocular/Visual - Other (Specify, __)	12.5% 2/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Eye disorders Ophthalmoplegia/diplopia (double vision)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Pain - Abdomen NOS	18.8% 3/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
General disorders Pain - Chest/thorax NOS	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
General disorders Pain - Other (Specify, __)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
General disorders Pain - Pain NOS	31.2% 5/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pain - Tumor pain	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Investigations Platelets	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	37.5% 6/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Injury, poisoning and procedural complications Rash: dermatitis associated with radiation - Chemoradiation	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Nervous system disorders Tremor	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Skin and subcutaneous tissue disorders Ulceration	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Nervous system disorders Vasovagal episode	6.2% 1/16 • Patients were followed until disease progression, death, or six months after completion of treatment.
Gastrointestinal disorders Vomiting	18.8% 3/16 • Patients were followed until disease progression, death, or six months after completion of treatment.

Additional Information

Robin V. Johnson

UNC Lineberger Comprehensive Cancer Center

Phone: 919-966-1125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60