Phase 2
Completed N=70
A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00887549 ↗Enrolled (actual)
70
Serious AEs
58.6%
Results posted
Aug 2011
Primary outcomePrimary: Progression Free Survival (PFS) — 5.5 months — p=<0.0001
Summary
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With Tumor Response (Tumor Response Rate) |
30 | — |
| SECONDARY Percentage of Participants With Concordance Between Local and Central Histological Diagnosis |
78.6 | — |
| SECONDARY Percentage of Participants Surviving at 18 Months (Overall Survival Rate) |
37.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type
- Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work
- Patients must not have had previous chemotherapy treatment for lung cancer
- Patients must not have had radiotherapy in the last 30 days
- Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan
- Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory
- Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
Exclusion Criteria
- Patients cannot have received other investigational drugs within the last 30 days
- Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely
- Patients cannot have a current second primary malignant tumor
- Patients cannot be having current treatment with any other anti-tumor therapy
- Patients cannot have had a yellow fever vaccination within 30 days of enrolment
- Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
- Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
- Patients who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00887549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.