Lung Cancer
Conditions
Keywords
TEMOZOLOMIDE, Lung
Brief summary
The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma. As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.
Interventions
DRUGTemozolomide
Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day.
Sponsors
Schering-Plough
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have pathologically confirmed SCLC at MSKCC that has progressed after one or two chemotherapy regimens. * At least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment. * Karnofsky performance status \> or = to 60%. * Patients must have measurable disease, this can include brain metastases. * Patients must have normal organ and marrow function as defined below: * \- leukocytes \> 3,000/mcL * platelets \> 100,000/mcL * total bilirubin \< 1.5 mg/dL * AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal * Creatinine \< 2.0 mg/dl * For women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide. * Men and women of childbearing potential must agree to practice adequate contraception. * Ability to understand and the willingness to sign a written informed consent document. * Both men and women of all races and ethnic groups are eligible for this trial.
Exclusion criteria
* Patients who have not recovered from adverse events of previous therapies. * Patients receiving other investigational agents. * Patients with leptomeningeal involvement. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide. * Women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Objective Overall Response | 2 years | The objective response is defined as all complete responses and partial responses based on the modified RECIST.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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. 200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles. | 25 |
| 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. 75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles. | 67 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Patient Ineligible | 0 | 1 |
| Overall Study | Patient Not Treated | 0 | 1 |
| Overall Study | Progressive Disease | 1 | 0 |
Baseline characteristics
| Characteristic | 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. | 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 45 Participants | 56 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 22 Participants | 36 Participants |
| Sex: Female, Male Female | 16 Participants | 37 Participants | 53 Participants |
| Sex: Female, Male Male | 9 Participants | 30 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 25 | 51 / 67 |
| serious Total, serious adverse events | 12 / 25 | 20 / 67 |
Outcome results
Primary
The Objective Overall Response
The objective response is defined as all complete responses and partial responses based on the modified RECIST.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.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Partial Response (PR) | 7 participants |
| 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Stable Disease (SD) | 7 participants |
| 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Progression of Disease (POD) | 9 participants |
| 200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Complete Response (CR) | 0 participants |
| 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Stable Disease (SD) | 19 participants |
| 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Complete Response (CR) | 1 participants |
| 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Partial Response (PR) | 12 participants |
| 75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. | The Objective Overall Response | Progression of Disease (POD) | 31 participants |