Phase I Trial Of Cisplatin And KML-001 In Advanced Non-Small Cell Lung Cancer and Other Platinum Responsive Malignancies

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer or other
"platinum responsive malignancies" , including but not limited to: esophageal cancer,
ovarian cancer, germ cell malignancies , transitional cell cancer etc. that are not
curable with chemotherapy, surgery or radiotherapy. A tissue block or fresh tissue
biopsy is required. Patients with CNS metastases which are symptomatic must have
received therapy (surgery, XRT, gamma knife) and be neurologically stable and off
steroids. Patients with asymptomatic lesions without significant edema and no
evidence of shift are allowed to participate without prior CNS therapy. Such
patients are anticipated to receive specific CNS therapy after 2-4 courses of
therapy.

- Patients may have received prior systemic chemotherapy or radiation therapy. At
least 2 weeks should have elapsed since the last treatment and patients should have
recovered from previous significant toxicity (i.e. to grade 1 or less). Alopecia,
skin discoloration etc. are not considered significant toxicities. There is no limit
on the number of prior therapies. Patients may have received prior cisplatin or
other platinum regimens.

- ECOG Performance Status less than or equal to 2.

- Patient 18 years of age or older.

- Absolute Granulocyte Count greater than or equal to 1.5 x 10^9

- Platelet count greater than or equal to 100 x 10^9

- Serum creatinine within normal limits, or an estimated or measured creatinine
clearance greater than or equal to 65 ml/min.

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent.

- Serum calcium, magnesium and potassium must be within normal limits.

Exclusion Criteria:

- Patients must not have serious infection or other serious underlying medical
condition which would impair the ability of the patient to receive protocol
treatment. These need not be specified in the history and physical and can be
documented through signature on the eligibility checklist. Severe, active
co-morbidity, defined as follows:

1. Current uncontrolled cardiac disease;

2. Corrected (Bazett) QTc interval of > .50 ms (male) or > .52 ms (female);

3. Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration;

4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 4 weeks of
registration;

5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;

6. Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current CDC
definition or patients known to be HIV positive.

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception.

- Pre-existing ≥ grade 2 peripheral neuropathy.