A Multicenter, Phase II Trial of the Safety and Efficacy of Amplimexon® (Imexon for Injection) in Combination With Taxotere® (Docetaxel) for Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
1. Subjects with histologically or cytologically confirmed NSCLC.
2. Subject with metastatic disease (Appendix D) who have received no more than 2 prior
chemotherapy regimens for their metastatic disease.
- Adjuvant chemotherapy is considered one prior regimen.
- Immunological and targeted agents such as bevacizumab, erlotinib or gefitinib
are considered prior regimens.
3. Subjects must have at least one measurable lesion by RECIST criteria (Appendix C).
If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD,
and if the only target lesion is a single lesion, a cytological or histological
confirmation of NSCLC is required.
4. Resolution of all chemotherapy or radiotherapy-related toxicities to CTCAE grade 1 or
lower, except for stable sensory neuropathy of < grade 2 and/or alopecia.
5. Men and women age > 18 years.
6. ECOG performance status of 0 - 1 (Appendix E).
7. Not pregnant nor lactating.
8. If of child bearing potential must be able and agree to use adequate contraception.
9. Adequate renal function defined by:
- serum creatinine level < 2.0 mg/dL.
10. G6PD (quantitative) greater than or equal to the lower limit of normal.
11. Adequate hematologic function defined by:
- absolute neutrophil count (ANC) >1,500/mm³, and
- platelet count > 100,000/mm³, and
- hemoglobin level > 9 g/dL.
12. Adequate hepatic function defined by:
- total bilirubin level < ULN, and
- AST and ALT levels < 1.5 x ULN
- Alkaline phosphatase < 2.5x ULN
13. Prior brain metastasis are allowed but must have been treated and controlled for > 1
month prior and be off steroids.
14. Subjects willing and able to comply with the study protocol for the duration of the
15. Able to render written informed consent and to follow protocol requirements.
1. Subjects who have received previous treatment with docetaxel.
2. Subjects who have received chemotherapy or radiation treatments within 4 weeks of
study treatment start.
3. Prior high dose chemotherapy with hematopoietic stem cell rescue within the past two
4. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring
active treatment, including the use of oxygen and/or the medical management of
recurrent pleural effusions.
5. Subjects with meningeal carcinomatosis.
6. Women who are pregnant or breast-feeding, women of child bearing potential (WOCBP)
with either a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or
equivalent units of HCG) or no pregnancy test; WOCBP unless (1) surgically sterile
(hysterectomy, or bilateral oophorectomy) or (2) not using adequate measures of
contraception in the opinion of the Investigator. Perimenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential.
7. Severe or uncontrolled intercurrent infection or other illness.
8. Significant cardiovascular disease including but not limited to a history of
congestive heart failure of > NYHA grade II (Appendix E), unstable angina or a
myocardial infarction within the past six months, or serious and uncontrolled
9. Subjects with organ allografts.
10. Subjects who have had a prior malignancy, other than carcinoma in situ of the cervix,
non-melanoma skin cancer, and superficial bladder cancer unless the prior malignancy
was diagnosed and definitively treated > 5 years previously with no subsequent
evidence of recurrence.
11. Subjects with pre-existing neuropathy > CTCAE Grade 2.
12. Subjects with other significant disease or disorders that, in the opinion of the
Investigator, would exclude the subject from the study