Non-Small Cell Lung Carcinoma
Conditions
Keywords
Non Small Cell Lung Cancer, Lung Cancer, Metastatic Lung Cancer, Inoperable Lung Cancer, Advanced Lung Cancer, Large Cell Lung Cancer, Adenocarcinoma, lung, Squamous Cell Carcinoma, lung, Squamous Cell Lung Cancer, Large Cell Carcinoma, lung, Cancer of the Lung, Carcinoma, Bronchogenic
Brief summary
The goals of this study are: * to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin. * to assess response to treatment in patients with NSCLC six months after beginning study treatment.
Interventions
DRUGMotexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Sponsors
Pharmacyclics LLC.
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
* 18 years or older * Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen * ECOG performance status score of 0 or 1
Exclusion criteria
* Laboratory values indicating inadequate function of bone marrow, liver, or kidneys * Symptomatic or uncontrolled brain metastases * Evidence of meningeal metastasis * \> 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed \> 12 months prior to regiment) * Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 month progression free survival | up to 2 years | proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression | up to 2 years | Time to progression is defined as the time from first dose of MGd to first evidence of progression. |
| Progression free survival | up to 2 years | Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death. |
| Response rate (CR+PR) by RECIST criteria | up to 2 years | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment. |
| Overall survival | up to 2 years | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed. |
| Clinical benefit rate (CR+PR+SD) | up to 2 years | Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment |
| Safety and tolerability of MGd and pemetrexed | up to 2 years | All patients who receive any MGd will be included in the safety summaries and analyses |
| Duaration of reponse (CR+PR) | up to 2 years | Duration of response (CR + PR) is defined as the time from first response to the time of disease progression. |
Countries
United States
Outcome results
None listed