Recurrent Endometrial Carcinoma
Conditions
Brief summary
This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed description
PRIMARY OBJECTIVES: I. Determine the 6-month progression-free survival of patients with recurrent or persistent endometrial carcinoma treated with lapatinib. II. Determine the nature and degree of toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the objective response rate in patients treated with this drug. II. Determine the duration of progression-free survival and overall survival in patients treated with this drug. III. Determine the effects of prognostic factors, such as initial performance status and tumor grade, in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-82 patients will be accrued for this study within 30-67 months.
Interventions
DRUGlapatinib ditosylate
Sponsors
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed endometrial carcinoma * Recurrent or persistent disease * Histologic confirmation of the original primary tumor is required * Refractory to curative therapy or standard treatments * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan * Must have at least 1 target lesion * Tumors within a previously irradiated field are considered non-target lesions * Disease in an irradiated field as the only site of measurable disease is considered a target lesion provided there has been clear progression of the lesion since the completion of prior radiotherapy * Must have received 1 prior chemotherapy regimen for endometrial carcinoma * Initial therapy may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * No more than 1 additional prior cytotoxic regimen for recurrent or persistent disease * Tumor accessible to guided core needle or fine needle biopsy * Ineligible for a higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population) * Performance status - GOG 0-2 (for patients who have received 1 prior treatment regimen) * Performance status - GOG 0-1 (for patients who have received 2 prior treatment regimens) * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * Cardiac ejection fraction normal by echocardiogram or MUGA * No gastrointestinal (GI) tract disease resulting in an inability to take oral medication * No malabsorption syndrome * No requirement for IV alimentation * No uncontrolled inflammatory GI disease (e.g., Crohn's or ulcerative colitis) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No sensory or motor neuropathy \> grade 1 * No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * At least 4 weeks since prior immunologic agents for the malignant tumor * No prior trastuzumab (Herceptin\^®) or any target-specific therapy directed to the HER family (e.g., gefitinib, erlotinib, or cetuximab) * At least 6 weeks since prior nitrosoureas or mitomycin for the malignant tumor and recovered * No prior non-cytotoxic chemotherapy for recurrent or persistent disease * At least 1 week since prior hormonal therapy for the malignant tumor * Concurrent hormone replacement therapy allowed * Recovered from prior radiotherapy * Recovered from prior surgery * No prior surgery affecting absorption * At least 4 weeks since other prior therapy for the malignant tumor * No prior lapatinib * No prior anticancer treatment that would preclude study treatment * Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased monitoring of INR * No concurrent CYP3A4 inducers or inhibitors * No concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Progression-free Survival > 6 Months | For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years. | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Every cycle during treatment and 30 days after the last cycle of therapy. | The frequency and severity of all toxicities are tabulated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From study entry to death or last contact, up to 5 years. | The observed length of life from entry into the study to death or the date of last contact. |
| Percentage of Patients With Tumor Response | For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years. | Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Prognostic Factor (Histologic Grade) | Baseline | G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported. |
| Prognostic Factors (Performance Status) | Baseline | Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work. |
| Duration of Progression-free Survival | Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
Countries
United States
Participant flow
Recruitment details
The study was activated on 11/1/2004 and closed to accrual on 9/26/2005.
Participants by arm
| Arm | Count |
|---|---|
| GW572016 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Never treated | 1 |
Baseline characteristics
| Characteristic | GW572016 |
|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 11.1 |
| Age, Customized 30-39 years | 2 participants |
| Age, Customized 40-49 years | 4 participants |
| Age, Customized 50-59 years | 3 participants |
| Age, Customized 60-69 years | 13 participants |
| Age, Customized 70-79 years | 8 participants |
| Histologic Type Adenocarcinoma, Unspecified | 2 participants |
| Histologic Type Clear Cell Carcinoma | 3 participants |
| Histologic Type Endometrioid Adenocarcinoma | 16 participants |
| Histologic Type Mixed Epithelial Carcinoma | 2 participants |
| Histologic Type Serous Adenocarcinoma | 7 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent | 30 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 10 / 30 |
Outcome results
Primary
Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
The frequency and severity of all toxicities are tabulated.
Time frame: Every cycle during treatment and 30 days after the last cycle of therapy.
Population: Eligible and evaluable patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Leukopenia | 29 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Genitourinary/renal | 29 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Musculoskeletal | 27 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Hemorrhage | 29 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pain | 25 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Lymphatics | 29 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Anemia | 11 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Ocular | 26 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Cardiovascular | 28 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pulmonary | 27 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Other hematologic | 27 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Constitutional | 13 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Thrombocytopenia | 28 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Neuropathy | 29 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Dermatologic | 22 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Metabolic | 20 Participants |
| GW572016 | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Gastrointestinal | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Dermatologic | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Other hematologic | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Genitourinary/renal | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pain | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Thrombocytopenia | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Lymphatics | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Metabolic | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Hemorrhage | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Constitutional | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Leukopenia | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Neuropathy | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Anemia | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pulmonary | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Ocular | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Musculoskeletal | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Gastrointestinal | 12 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Cardiovascular | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Musculoskeletal | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Leukopenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Thrombocytopenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Anemia | 10 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Cardiovascular | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Constitutional | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Dermatologic | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Gastrointestinal | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Genitourinary/renal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Hemorrhage | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Lymphatics | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Metabolic | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Neuropathy | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Other hematologic | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Ocular | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pain | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pulmonary | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Genitourinary/renal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Gastrointestinal | 6 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Musculoskeletal | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Dermatologic | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Metabolic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Constitutional | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Neuropathy | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Cardiovascular | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Other hematologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Anemia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Leukopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Ocular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pulmonary | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Hemorrhage | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pain | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Genitourinary/renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Anemia | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Metabolic | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Constitutional | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Gastrointestinal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Pain | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Ocular | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Neuropathy | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Cardiovascular | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 | Leukopenia | 0 Participants |
Primary
Percentage of Patients With Progression-free Survival > 6 Months
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.
Population: Eligible and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW572016 | Percentage of Patients With Progression-free Survival > 6 Months | 10 percentage of participants |
Secondary
Duration of Progression-free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Population: Eligible and evaluable patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GW572016 | Duration of Progression-free Survival | 1.82 months |
Secondary
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years.
Population: Eligible and treated patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GW572016 | Overall Survival | 7.33 Months |
Secondary
Percentage of Patients With Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.
Population: Eligible and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GW572016 | Percentage of Patients With Tumor Response | 3.3 percentage of participants |
Secondary
Prognostic Factor (Histologic Grade)
G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Time frame: Baseline
Population: Eligible and evaluable
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW572016 | Prognostic Factor (Histologic Grade) | Grade 1 | 3 Participants |
| GW572016 | Prognostic Factor (Histologic Grade) | Grade 2 | 6 Participants |
| GW572016 | Prognostic Factor (Histologic Grade) | Grade 3 | 14 Participants |
| GW572016 | Prognostic Factor (Histologic Grade) | Not graded | 7 Participants |
Secondary
Prognostic Factors (Performance Status)
Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction. Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Time frame: Baseline
Population: Eligible and evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GW572016 | Prognostic Factors (Performance Status) | Performance status 0 | 19 Participants |
| GW572016 | Prognostic Factors (Performance Status) | Performance status 1 | 11 Participants |