A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
Inclusion Criteria:
- Histologically or cytologically confirmed recurrent NSCLC
- Age of 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to RECIST
- Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients
who have received more than one prior chemotherapy regimens may participate in Part A
of the study only.
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- At least 3 weeks from prior systemic treatments including investigational anti-cancer
therapy; at least 7 days from prior radiation therapy; and have recovered from prior
toxicities
- At least 3 weeks from major surgery
- Patient must be able to swallow capsules
- Agree to practice effective contraception during the entire study period and for one
month after being discontinued from the study unless documentation of infertility
exists. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
- NSCLC histology contains a component of small cell lung cancer
- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI
scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational
agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Cancer other than NSCLC that has been treated with chemotherapy or biological therapy
in the past 5 years with the exception of adequately treated in situ cervical cancer,
and basal or squamous cell skin cancer; patients who received only hormonal therapy
in the neoadjuvant or adjuvant setting in the past 5 years may participate in this
study
- Pregnant or lactating women
- Known to be HIV-positive