Trial Outcomes & Findings for Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy (NCT NCT00084487)

Last Updated: 2014-05-23

Results Overview

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2014-05-23

Participant Flow

Patients were recruited for Cleveland area medical hospitals between November 2004 and November 2007.

Participant milestones

Participant milestones
Measure	Treatment (Rebeccamycin Analogue) Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Rebeccamycin Analogue) Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Overall Study Death	1

Baseline Characteristics

Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 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	4 Participants n=5 Participants
Race (NIH/OMB) White	16 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	20 participants n=5 Participants
ECOG Performance Status 0	5 participants n=5 Participants
ECOG Performance Status 1	10 participants n=5 Participants
ECOG Performance Status 2	5 participants n=5 Participants
Prior Therapy Chemotherapy	20 participants n=5 Participants
Prior Therapy Radiation	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Intent to treat

Outcome measures

Outcome measures
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Objective Response Rate Estimated as the Proportion of Responders Partial Response (PR)	2 participants Interval 3.0 to 30.0
Objective Response Rate Estimated as the Proportion of Responders Stable Disease (SD)	6 participants
Objective Response Rate Estimated as the Proportion of Responders Progressive Disease (PD)	12 participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Intent to treat

Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.

Outcome measures

Outcome measures
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Progression Free Survival	2 months Interval 1.21 to 5.15

PRIMARY outcome

Timeframe: Up to 4 years

Population: Intent to treat

Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.

Outcome measures

Outcome measures
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Overall Survival	6.7 months Interval 3.3 to 8.0

SECONDARY outcome

Timeframe: 6 months

Population: Intent to treat

Percentage of patients that are progression free at 6 months.

Outcome measures

Outcome measures
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Progression Free Survival	20 percentage of participants Interval 6.2 to 39.3

SECONDARY outcome

Timeframe: 1 year

Population: Intent to treat

Percentage of patients alive at 1 year

Outcome measures

Outcome measures
Measure	Treatment (Rebeccamycin Analogue) n=20 Participants Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Overall Survival	10 percentage of participants Interval 1.7 to 27.2

Adverse Events

Treatment (Rebeccamycin Analogue)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Rebeccamycin Analogue) n=20 participants at risk Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Respiratory, thoracic and mediastinal disorders Obstruction/stenosis of airway: Bronchus	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Platelets	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Cardiac disorders Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Infections and infestations Lung Infection	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Nausea	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Cardiac disorders Cardiac troponin T (cTnT)	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Cardiac disorders Cardiac-ischemia/infarction	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Death not associated with CTCAE term - Multi-organ failure	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Diarrhea patients without colostomy	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.

Other adverse events

Other adverse events
Measure	Treatment (Rebeccamycin Analogue) n=20 participants at risk Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. becatecarin : Given IV
Gastrointestinal disorders Abdominal pain or cramping	20.0% 4/20 • Adverse events were collected while patients were on study, up to four years.
Metabolism and nutrition disorders Anorexia	45.0% 9/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Ataxia (incoordination)	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Musculoskeletal and connective tissue disorders Back Pain	20.0% 4/20 • Adverse events were collected while patients were on study, up to four years.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Respiratory, thoracic and mediastinal disorders Chest Congestion/Flu like symptoms	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Cardiac disorders Chest Pressure	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Cognitive disturbance/learning problems	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Confusion	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Constipation	35.0% 7/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Dehydration	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Diarrhea patients without colostomy	25.0% 5/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Dizziness/lightheadedness	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Dyspepsia/heartburn	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Leukocytes (total WBC)	30.0% 6/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Lymphopenia	25.0% 5/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Mood alteration-anxiety, agitation	15.0% 3/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Mood alteration-depression	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Mouth dryness	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Edema	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Fatigue (lethargy, malaise, asthenia)	65.0% 13/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Headache	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Hemoglobin	55.0% 11/20 • Adverse events were collected while patients were on study, up to four years.
Vascular disorders Hypotension	15.0% 3/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Insomnia	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Intermittent Halatosis	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Nausea	55.0% 11/20 • Adverse events were collected while patients were on study, up to four years.
Nervous system disorders Neuropathy-sensory	5.0% 1/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	35.0% 7/20 • Adverse events were collected while patients were on study, up to four years.
Musculoskeletal and connective tissue disorders Pain NOS	20.0% 4/20 • Adverse events were collected while patients were on study, up to four years.
Blood and lymphatic system disorders Platelets	40.0% 8/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Rigors, chills	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	10.0% 2/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Taste disturbance (dysgeusia)	25.0% 5/20 • Adverse events were collected while patients were on study, up to four years.
Gastrointestinal disorders Vomiting	25.0% 5/20 • Adverse events were collected while patients were on study, up to four years.
General disorders Weight loss	15.0% 3/20 • Adverse events were collected while patients were on study, up to four years.

Additional Information

Afshin Dowlati MD

Case Comprehensive Cancer Center

Phone: 216-844-1228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60