Trial Outcomes & Findings for Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer (NCT NCT00281827)

Last Updated: 2017-12-28

Results Overview

Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

At end of 3 -21 day cycles of treatment

Results posted on

2017-12-28

Participant Flow

Patients were recruited from 3 participating study centers.

Participant milestones

Participant milestones
Measure	Intent-to-Treat Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intent-to-Treat n=22 Participants Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: At end of 3 -21 day cycles of treatment

Population: 2 of 22 patients did not receive all 3 drugs for all 3 cycles - only 20 patients achieved this and are thereby included here in the evaluable population analysis.

Outcome measures

Outcome measures
Measure	Evaluable Patients n=20 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Reporting Clinical Response Complete Response	0 Participants
Number of Patients Reporting Clinical Response Pathological Complete Response	0 Participants
Number of Patients Reporting Clinical Response Partial Response	14 Participants
Number of Patients Reporting Clinical Response Stable Disease	4 Participants
Number of Patients Reporting Clinical Response Progressive Disease	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Calculated from study entry date to date of recurrence or date of death, whichever came first.

Calculated from date of enrollment to date of recurrence or death, whichever came first

Outcome measures

Outcome measures
Measure	Evaluable Patients n=22 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Disease-free at 1 Year	14 Participants Interval 1.117 to 2.954

SECONDARY outcome

Timeframe: 2 Years

Calculated from date of enrollment to date of recurrence or death, whichever came first

Outcome measures

Outcome measures
Measure	Evaluable Patients n=22 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Disease-free at 2 Years	8 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Calculated from date of first date of enrollment.

Participants who were alive at one year from date of enrollment .

Outcome measures

Outcome measures
Measure	Evaluable Patients n=22 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Alive at 1 Year (Survival)	21 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Calculated from date of first date of enrollment to date of death.

Participants who were alive at 2 years from date of enrollment.

Outcome measures

Outcome measures
Measure	Evaluable Patients n=22 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Alive at 2 Years (Survival)	16 Participants

SECONDARY outcome

Timeframe: Up to 56 months

Population: Calculated from study entry date to date of death or censored at date of last contact.

Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).

Outcome measures

Outcome measures
Measure	Evaluable Patients n=22 Participants Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
Number of Patients Alive at 56 Months (End of Study)	8 Participants Interval 1.938 to

Adverse Events

Intent-to-Treat

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intent-to-Treat n=22 participants at risk；n=19 participants at risk Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
Vascular disorders Carotid stenosis	5.3% 1/19 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.

Other adverse events

Other adverse events
Measure	Intent-to-Treat n=22 participants at risk；n=19 participants at risk Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
Skin and subcutaneous tissue disorders Alopecia	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Blood and lymphatic system disorders Anemia	31.8% 7/22 • Number of events 10 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Anorexia	13.6% 3/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Anxiety	9.1% 2/22 • Number of events 4 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Appetite loss	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Breast, left, soreness	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Cold sensation	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Constipation	77.3% 17/22 • Number of events 18 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Cough	22.7% 5/22 • Number of events 7 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Depression	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Diarrhea	27.3% 6/22 • Number of events 6 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Dizziness	31.8% 7/22 • Number of events 8 • Events were collected from Day 1 of study through 30 days post last treatment.
Eye disorders Double vision	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Dry skin	9.1% 2/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Dyseugsia	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Dysphagia	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Ecchymosis	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Blood and lymphatic system disorders Edema, extremity	22.7% 5/22 • Number of events 7 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Edema, facial	4.5% 1/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Metabolism and nutrition disorders Elevated transaminase	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Vascular disorders Epistaxis/nosebleed	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Erythemia intravenous arm site	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Fainting spell	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Fatigue	59.1% 13/22 • Number of events 22 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Fever episode	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Flu-like symptoms	18.2% 4/22 • Number of events 5 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders General body aches	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders General malaise	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Headaches, intermittent	13.6% 3/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Ear and labyrinth disorders Hearing loss diagnosis	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Heartburn	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Hemoptisis	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness, loss of voice	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Endocrine disorders Hot flashes	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Hyperpigmentation of skin on nose	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Hypersensitive to cold	4.5% 1/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Metabolism and nutrition disorders Hypokalemia	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Cardiac disorders Hypotension	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Irritable	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Itching/pruritus	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Leg aches	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Moodiness	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Mouth lesions (bumps)	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Mouth/tongue sensitivity	9.1% 2/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Mucositis	13.6% 3/22 • Number of events 4 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Muscle aches	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Muscle pain	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Nausea	63.6% 14/22 • Number of events 18 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Neuropathy, lower extremities	18.2% 4/22 • Number of events 5 • Events were collected from Day 1 of study through 30 days post last treatment.
Blood and lymphatic system disorders Neutropenia	54.5% 12/22 • Number of events 14 • Events were collected from Day 1 of study through 30 days post last treatment.
Renal and urinary disorders Nocturia	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Numbness, jaw and cheek	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Numbness, right side	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Infections and infestations Oral candidiasis	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Pain, PIC line site	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Pain, ankle	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain, central chest	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain, ear	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain, jaw	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain, low back	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain, rib	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Pain/cramps, abdominal	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Rash, body	45.5% 10/22 • Number of events 12 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Rash, facial	13.6% 3/22 • Number of events 4 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Rash, peripheral	27.3% 6/22 • Number of events 7 • Events were collected from Day 1 of study through 30 days post last treatment.
Ear and labyrinth disorders Right ear plugged	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Shortness of breath	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Sinus infection	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Somnolence	18.2% 4/22 • Number of events 4 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Sore throat	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Infections and infestations Strep throat	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Skin and subcutaneous tissue disorders Thinning nails	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Blood and lymphatic system disorders Thrombocytopenia	13.6% 3/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Tingling toes and feet	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Tingling, lips	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Ear and labyrinth disorders Tinnitus	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Tooth abscess/infection	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Tooth, cracked	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Tremor, upper extremity, hand	13.6% 3/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	9.1% 2/22 • Number of events 2 • Events were collected from Day 1 of study through 30 days post last treatment.
Renal and urinary disorders Urinary tract infection	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
General disorders Voice changes	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Vomiting	18.2% 4/22 • Number of events 4 • Events were collected from Day 1 of study through 30 days post last treatment.
Nervous system disorders Weakness	13.6% 3/22 • Number of events 3 • Events were collected from Day 1 of study through 30 days post last treatment.
Musculoskeletal and connective tissue disorders Weakness, muscle	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.
Gastrointestinal disorders Xerostomia	4.5% 1/22 • Number of events 1 • Events were collected from Day 1 of study through 30 days post last treatment.

Additional Information

Arkadiusz Dudek, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-624-0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place