Clinical Study of Microdosing Carboplatin in Lung or Bladder Cancer

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Phase 0 Clinical trial, Human microdosing trial, Drug resistance, neoplasm, Carcinoma, Non-small cell lung, Urinary Bladder Neoplasm, Individualized Medicine, Carboplatin, Carboplatin-DNA adducts Read More

Inclusion Criteria:

• Participants must have clinical diagnosis of lung or bladder cancer. The term "clinical diagnosis" means that patients are diagnosed with NSCLC or bladder transitional cell carcinoma (TCC) based on imaging studies, but will need further biopsy/resection to obtain tissue in order to confirm the diagnosis. However, some patients may not have cancer as determined by pathology examination of the tissue, or may have a different cancer after biopsy/resection is performed. If the diagnosis of NSCLC or bladder cancer is confirmed, platinum-based chemotherapy must be planned either for neoadjuvant chemotherapy for Stage II or above bladder cancer, or palliative therapy for stage III or IV lung or bladder cancer regardless of patient participation in this study. Stage II or above TCC patients and stage IV NSCLC patients that will receive platinum-based chemotherapy will be eligible for this study. Patients with Stage III or IV lung or bladder cancer must have measurable lesion(s).
• Prior radiation or surgery is allowed, but should be finished at least 2 weeks prior to study enrollment. If a participant has prior radiation therapy, at least one measurable lesion outside of the radiation field should be available for the evaluation of response to chemotherapy.
• Participants must be 18 years or older. We do not see any patients with NSCLC or bladder TCC are diagnosed under the age of 18 years.
• ECOG performance status equal or less than to 2 (Karnofsky equal to or greater than 50%).
• Life expectancy of at least 3 months.
• Participants must have normal organ and marrow function as defined below: Absolute neutrophil count greater than/equal to 1,500/microL; Platelet count greater than/equal to 100,000/microL; Total bilirubin less than 1.5 X ULN; AST (SGOT) less than/equal to 2.5 X ULN; Creatinine less than 1.5 X ULN
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation.
• Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Patients must not receive concomitant radiation with chemotherapy if they do not have any measurable lesions outside of the radiation field.
• 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.
• Participants who are pregnant or nursing.
• Participants who are allergic to platinum agents.
• Participants who receive chemotherapy before that includes cisplatin, carboplatin or oxaliplatin.