Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
Conditions
Brief summary
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
Detailed description
OBJECTIVES: I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy. II. Determine the duration of remission and survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. 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. Patients are followed annually. PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.
Interventions
DRUGbecatecarin
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of small cell lung cancer (SCLC) * Limited or extensive stage * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Sensitive\* relapsed disease after only 1 prior chemotherapy regimen * Brain metastasis allowed provided the following criteria are met: * Stable brain disease * Not receiving irradiation * No steroid requirement to control symptoms * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present) * Bilirubin ≤ 1.5 mg/dL * Creatinine \< 2.0 mg/dL * Creatinine clearance ≥ 60 mL/min * No New York Heart Association class III or IV heart disease * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active or ongoing infection * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * See Disease Characteristics * See Disease Characteristics * See Disease Characteristics * Prior radiotherapy allowed * No other concurrent investigational agents * No other concurrent therapies for SCLC * No concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate Estimated as the Proportion of Responders | Up to 4 years | 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. |
| Progression Free Survival | Up to 4 years | 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. |
| Overall Survival | Up to 4 years | Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 6 months | Percentage of patients that are progression free at 6 months. |
| Overall Survival | 1 year | Percentage of patients alive at 1 year |
Countries
United States
Participant flow
Recruitment details
Patients were recruited for Cleveland area medical hospitals between November 2004 and November 2007.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Treatment (Rebeccamycin Analogue) |
|---|---|
| Age, Continuous | 61 years |
| ECOG Performance Status 0 | 5 participants |
| ECOG Performance Status 1 | 10 participants |
| ECOG Performance Status 2 | 5 participants |
| Prior Therapy Chemotherapy | 20 participants |
| Prior Therapy Radiation | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 20 |
| serious Total, serious adverse events | 7 / 20 |
Outcome results
Primary
Objective Response Rate Estimated as the Proportion of Responders
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.
Time frame: Up to 4 years
Population: Intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Rebeccamycin Analogue) | Objective Response Rate Estimated as the Proportion of Responders | Partial Response (PR) | 2 participants |
| Treatment (Rebeccamycin Analogue) | Objective Response Rate Estimated as the Proportion of Responders | Stable Disease (SD) | 6 participants |
| Treatment (Rebeccamycin Analogue) | Objective Response Rate Estimated as the Proportion of Responders | Progressive Disease (PD) | 12 participants |
Primary
Overall Survival
Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.
Time frame: Up to 4 years
Population: Intent to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Rebeccamycin Analogue) | Overall Survival | 6.7 months |
Primary
Progression Free Survival
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.
Time frame: Up to 4 years
Population: Intent to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Rebeccamycin Analogue) | Progression Free Survival | 2 months |
Secondary
Overall Survival
Percentage of patients alive at 1 year
Time frame: 1 year
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Rebeccamycin Analogue) | Overall Survival | 10 percentage of participants |
Secondary
Progression Free Survival
Percentage of patients that are progression free at 6 months.
Time frame: 6 months
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Rebeccamycin Analogue) | Progression Free Survival | 20 percentage of participants |