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A Phase 0 Clinical Trial of Microdosing Carboplatin and Molecular Profiling for Chemoresistance

Phase 0
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms

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Trial Information

A Phase 0 Clinical Trial of Microdosing Carboplatin and Molecular Profiling for Chemoresistance

Inclusion Criteria:

- Participants must have clinical diagnosis of lung or bladder cancer. Platinum-based
chemotherapy must be planned either for neoadjuvant chemotherapy for Stage II or
above bladder cancer, or palliative therapy for stage IV lung or bladder cancer no
matter whether patients participate in this study or not. Patients with Stage 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

- 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:

- Participants may not be receiving any other investigational agents.

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation of carboplatin-DNA monoadducts induced by microdoses of carboplatin with cancer response to carboplatin-based chemotherapy

Outcome Description:

Imaging studies (including CT, MRI, PET/CT and CXR) and cystoscopy will be performed to evaluate the response. The RECIST 1.1 will be used to determine the cancer response. Tumor response, including complete response (CR, or complete disappearance) or partial response (PR, at least a 30% decrease of target lesion) will be correlated with the patient's carboplatin-DNA monoadduct levels.

Outcome Time Frame:

Patients will be evaluated for response to chemotherapy after they have received 2 to 3 cycles of chemo that is about 6-9 weeks after treatment is started.

Safety Issue:


Principal Investigator

Chong-xian Pan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

November 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Urinary Bladder Neoplasms
  • Phase 0 Clinical trial
  • Human microdosing trial
  • Drug resistance, neoplasm
  • Carcinoma, Non-small cell lung
  • Urinary Bladder Neoplasm
  • Individualized Medicine
  • Carboplatin
  • Carboplatin-DNA adducts
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung



University of California, Davis Sacramento, California  95818