Head and Neck Cancer
Conditions
Brief summary
The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.
Interventions
DRUGTAS-106
6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Sponsors
Taiho Pharmaceutical Co., Ltd.
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
* Age 18 ≤ years old at study entry * Histologically confirmed head and neck carcinoma * Received prior platinum based regimen and developed disease progression or recurrence * Measurable disease according to RECIST guidelines
Exclusion criteria
* Radiological or clinical evidence of brain involvement or leptomeningeal disease * ≥ grade 2 peripheral neuropathy * History of another malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | From the date of registration until the earliest date of documented disease progression, death, or censoring event. | PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor Activity | Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter. | Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: 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., or similar text that was as accurate and appropriate. |
| Overall Survival | 12 months after enrollment of the last patient | Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011. |
| Safety | Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication. | Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC. |
Countries
Hong Kong, Singapore, Taiwan, United States
Participant flow
Recruitment details
The patient enrollment was started from 24/Sep/2008 and terminated as of 30/Sep/2010. In the nasopharyngeal carcinoma (NPC) subgroup and squamous cell carcinoma (SCCHN) subgroup of stage 1, 13 and 14 patients were enrolled, respectively. For both subgroups subsequent enrollment was not reopened for the second stage, thus 27 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| TAS-106 | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | TAS-106 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age Continuous | 56 years STANDARD_DEVIATION 7.96 |
| Region of Enrollment Hong Kong | 9 participants |
| Region of Enrollment Singapore | 5 participants |
| Region of Enrollment Taiwan | 1 participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 27 |
| serious Total, serious adverse events | 15 / 27 |
Outcome results
Primary
Progression Free Survival(PFS)
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
Time frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event.
Population: One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAS-106 | Progression Free Survival(PFS) | 51 day |
Secondary
Antitumor Activity
Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: 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., or similar text that was as accurate and appropriate.
Time frame: Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.
Population: Antitumor activity was the rate of best overall objective responses(complete response + partial response).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAS-106 | Antitumor Activity | 0 participants |
Secondary
Overall Survival
Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
Time frame: 12 months after enrollment of the last patient
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAS-106 | Overall Survival | 213 day |
Secondary
Safety
Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.
Time frame: Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.
Population: All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAS-106 | Safety | 27 number of participants |