Trial Outcomes & Findings for Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer (NCT NCT00062010)

NCT ID: NCT00062010

Last Updated: 2023-07-07

Results Overview

Number of eligible, treated participants in each response category by RECIST criteria

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Assessed every 6 weeks

Results posted on

2023-07-07

Participant Flow

Participants were recruited from ECOG member institutions between February 24, 2004 and August 22, 2007. The first patient was accrued on May 26, 2004.

Participant milestones

Participant milestones
Measure	IFN Alpha, 13-Cis-RA, Paclitaxel Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Study STARTED	37
Overall Study Eligible and Treated	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	IFN Alpha, 13-Cis-RA, Paclitaxel Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Overall Study Ineligible	3

Baseline Characteristics

Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IFN 13CRA Paclitaxel n=34 Participants Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Age, Continuous	60 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Region of Enrollment United States	34 participants n=99 Participants

PRIMARY outcome

Timeframe: Assessed every 6 weeks

Population: Eligible, treated patients

Number of eligible, treated participants in each response category by RECIST criteria

Outcome measures

Outcome measures
Measure	IFN 13CRA Paclitaxel n=34 Participants Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Response by RECIST Criteria (v 1.0) Partial Response	3 participants
Response by RECIST Criteria (v 1.0) Stable Disease	5 participants
Response by RECIST Criteria (v 1.0) Progressive Disease	11 participants
Response by RECIST Criteria (v 1.0) Unevaluable	15 participants

SECONDARY outcome

Timeframe: Assessed every 3 months for 1 year then every 6 months

Population: Eligible, treated patients

Time from registration to death.

Outcome measures

Outcome measures
Measure	IFN 13CRA Paclitaxel n=34 Participants Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Survival	6.2 months Interval 4.7 to 9.8

SECONDARY outcome

Timeframe: Assessed every 6 weeks

Population: Eligible, treated patients

Time from registration to documented disease progression (RECIST criteria) or death.

Outcome measures

Outcome measures
Measure	IFN 13CRA Paclitaxel n=34 Participants Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Progression-free Survival	2.0 months Interval 1.8 to 3.9

Adverse Events

IFN Alpha, 13-CRA, Paclitaxel

Serious events: 21 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IFN Alpha, 13-CRA, Paclitaxel n=34 participants at risk Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Blood and lymphatic system disorders Leukopenia	32.4% 11/34 • Assessed weekly during treatment
Blood and lymphatic system disorders Neutropenia	23.5% 8/34 • Assessed weekly during treatment
Blood and lymphatic system disorders Transfusion-Red Blood Cells	5.9% 2/34 • Assessed weekly during treatment
Vascular disorders Hypotension	2.9% 1/34 • Assessed weekly during treatment
General disorders Fatigue	20.6% 7/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Dehydration	5.9% 2/34 • Assessed weekly during treatment
Gastrointestinal disorders Dysphagia	2.9% 1/34 • Assessed weekly during treatment
Gastrointestinal disorders Pancreatitis	2.9% 1/34 • Assessed weekly during treatment
Gastrointestinal disorders Vomiting	2.9% 1/34 • Assessed weekly during treatment
Investigations Alkaline Phosphatase Increased	2.9% 1/34 • Assessed weekly during treatment
Investigations AST Increased	2.9% 1/34 • Assessed weekly during treatment
Investigations ALT Increased	2.9% 1/34 • Assessed weekly during treatment
Investigations Febrile Neutropenia	2.9% 1/34 • Assessed weekly during treatment
Infections and infestations Infection with Grade 3 or 4 Neutropenia	2.9% 1/34 • Assessed weekly during treatment
Infections and infestations Infection without Neutropenia	2.9% 1/34 • Assessed weekly during treatment
Investigations Amylase Increased	2.9% 1/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Hypertriglyceridemia	11.8% 4/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Hypokalemia	5.9% 2/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Hyponatremia	2.9% 1/34 • Assessed weekly during treatment
Investigations Lipase Increased	2.9% 1/34 • Assessed weekly during treatment
Musculoskeletal and connective tissue disorders Muscle Weakness	5.9% 2/34 • Assessed weekly during treatment
Nervous system disorders "Neuropathy, Motor"	2.9% 1/34 • Assessed weekly during treatment
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/34 • Assessed weekly during treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Assessed weekly during treatment

Other adverse events

Other adverse events
Measure	IFN Alpha, 13-CRA, Paclitaxel n=34 participants at risk Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
Blood and lymphatic system disorders Lymphopenia	5.9% 2/34 • Assessed weekly during treatment
Blood and lymphatic system disorders Thrombocytopenia	38.2% 13/34 • Assessed weekly during treatment
General disorders Edema	11.8% 4/34 • Assessed weekly during treatment
General disorders Fever	20.6% 7/34 • Assessed weekly during treatment
General disorders Rigors/Chills	41.2% 14/34 • Assessed weekly during treatment
Skin and subcutaneous tissue disorders Sweating	5.9% 2/34 • Assessed weekly during treatment
Investigations Weight Loss	17.6% 6/34 • Assessed weekly during treatment
General disorders Constitutional	5.9% 2/34 • Assessed weekly during treatment
Investigations Prothrombin Time Increased	5.9% 2/34 • Assessed weekly during treatment
Skin and subcutaneous tissue disorders Alopecia	32.4% 11/34 • Assessed weekly during treatment
Skin and subcutaneous tissue disorders Dry Skin	14.7% 5/34 • Assessed weekly during treatment
Skin and subcutaneous tissue disorders Pruritus	8.8% 3/34 • Assessed weekly during treatment
Skin and subcutaneous tissue disorders Rash/Desquamation	8.8% 3/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Anorexia	35.3% 12/34 • Assessed weekly during treatment
Gastrointestinal disorders Constipation	5.9% 2/34 • Assessed weekly during treatment
Gastrointestinal disorders Dyspepsia	5.9% 2/34 • Assessed weekly during treatment
Gastrointestinal disorders Mouth Dryness	14.7% 5/34 • Assessed weekly during treatment
Gastrointestinal disorders Nausea	23.5% 8/34 • Assessed weekly during treatment
Gastrointestinal disorders Stomatitis	11.8% 4/34 • Assessed weekly during treatment
Nervous system disorders Taste Disturbance	17.6% 6/34 • Assessed weekly during treatment
Gastrointestinal disorders Diarrhea	11.8% 4/34 • Assessed weekly during treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 2/34 • Assessed weekly during treatment
Investigations Bilirubin Increased	14.7% 5/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Hyperglycemia	5.9% 2/34 • Assessed weekly during treatment
Metabolism and nutrition disorders Hypomagnesemia	5.9% 2/34 • Assessed weekly during treatment
Psychiatric disorders Confusion	5.9% 2/34 • Assessed weekly during treatment
Nervous system disorders Dizziness/Lightheadedness	11.8% 4/34 • Assessed weekly during treatment
Psychiatric disorders Insomnia	8.8% 3/34 • Assessed weekly during treatment
Psychiatric disorders Depression	11.8% 4/34 • Assessed weekly during treatment
Nervous system disorders Neuropathy, Sensory	32.4% 11/34 • Assessed weekly during treatment
Gastrointestinal disorders Pain, Abdominal	5.9% 2/34 • Assessed weekly during treatment
Musculoskeletal and connective tissue disorders Arthralgia	32.4% 11/34 • Assessed weekly during treatment
Musculoskeletal and connective tissue disorders Pain, Bone	5.9% 2/34 • Assessed weekly during treatment
Nervous system disorders Headache	17.6% 6/34 • Assessed weekly during treatment
Musculoskeletal and connective tissue disorders Myalgia	14.7% 5/34 • Assessed weekly during treatment
General disorders Pain, Other	5.9% 2/34 • Assessed weekly during treatment
Investigations Creatinine Increased	8.8% 3/34 • Assessed weekly during treatment

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place