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A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors, Leukemia, Lymphocytic, Acute, Pediatric, Leukemia, Lymphocytic, Acute, Adult, Leukemia, Myelocytic, Acute, Pediatric, Leukemia, Myelocytic, Acute, Adult, Myelodysplastic Syndromes, Adult

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Trial Information

A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

- Have a pathologic diagnosis of advanced solid tumors

- After MTD is established, patients must have a measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) criteria

- Be greater than or equal to 18 years old

- Not eligible for therapy of higher curative potential

- Have a Karnofsky Performance Status (KPS) greater than or equal to 70

- Have an estimated life expectancy of greater than or equal to 12 weeks

- Have a negative serum or urine pregnancy test within 7 days of study enrollment (if
patient is a female of childbearing potential)

- Male and female patients who are fertile must agree to use an effective barrier
method of birth control (latex condom, diaphragm, cervical cap, etc.) to avoid

- Sign a written informed consent form

- Able to comply with study procedures and follow-up examinations

- Have adequate organ function as indicated by the following laboratory values,
obtained within 2 weeks prior to registration: ANC: greater than or equal to 1.5 × 10
9th/L; Platelets: greater than or equal to 100 × 10 9th/L; Serum bilirubin: less
than 2.0 mg/dL; AST and ALT: less than 3 x ULN (Institutional Upper Limit of Normal)
without liver involvement OR less than 5 x ULN(*) with liver involvement; Serum
creatinine: less than 2.0 mg/dL; Echocardiogram shortening fraction: greater than or
equal to 28%(Not on pharmacologic support); or Ejection fraction greater than or
equal to 50% (Not on pharmacologic support).

Exclusion Criteria:

- Received previous treatment with clofarabine.

- Have an active, uncontrolled systemic infection considered opportunistic, life
threatening, or clinically significant at the time of treatment.

- Prior malignancy with less than a 2-year disease-free interval, except for adequately
treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.

- Are pregnant or lactating.

- Have a psychiatric disorder(s) that would interfere with consent, study
participation, or follow-up.

- Have received any chemotherapy, major surgery, or irradiation, whether conventional
or investigational, < 4 weeks before enrollment in this study (6 weeks for
mitomycin-C or nitrosourea) and/or have not recovered from acute toxicities of all
previous therapy prior to enrollment.

- Have any other severe concurrent disease, which, in the judgment of the investigator,
would make the patient inappropriate for entry into this study (eg, uncontrolled
severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic
attacks, uncontrolled symptomatic coronary artery disease, etc.).

- Have received prior radiation therapy to greater than or equal to 25% of the bone
marrow (eg, no whole pelvic irradiation is allowed) and have not recovered from the
acute side effects of radiotherapy.

- Have received prior radiation therapy to the mediastinal region.

- Have a broncho-alveolar pattern evident on chest x-ray.

- Have symptomatic or untreated central nervous system (CNS) metastases.

Type of Study:


Study Design:


Outcome Measure:

The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

August 2007

Related Keywords:

  • Solid Tumors
  • Leukemia, Lymphocytic, Acute, Pediatric
  • Leukemia, Lymphocytic, Acute, Adult
  • Leukemia, Myelocytic, Acute, Pediatric
  • Leukemia, Myelocytic, Acute, Adult
  • Myelodysplastic Syndromes, Adult
  • CLO151
  • Clolar
  • Pediatric ALL and AML
  • Adult ALL and AML and MDS
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neoplasms



Mary Crowley Medical Research Center Dallas, Texas  75246
US Oncology Tyler Cancer Center Tyler, Texas  75702