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Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"


Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in
patients with advanced solid tumors will be determined.

When the recommended phase 2 dose has been determined, the specified dose will be used to
determine if Karenitecin is effective in the treatment of patients with relapsed or
refractory non-small cell lung cancer.

Inclusion Criteria


Inclusion Criteria

- Patients entering the Phase 1 portion of the study must have a histologically or
cytologically documented diagnosis of cancer (solid tumors) refractory to
conventional therapeutic modalities or for which no conventional treatment exists.

- Patients entering the Phase 2 portion of the study must have a histologically or
cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.

- Patients entering the Phase 1 portion of the study can have either measurable or
evaluable disease.

- Patients entering the Phase 2 portion of the study must have measurable disease
meeting RECIST criteria.

- Patients must have an ECOG performance status of less than or equal to 1.

- More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from
previous treatment with nitrosoureas or mitomycin-C.

- Patients must have fully recovered from the toxic effects of prior therapy.

- Patients entering the Phase 1 portion of the study may have received up to two prior
chemotherapy programs including adjuvant or neoadjuvant therapy.

- Patients entering the Phase 2 portion of the study may have received only one prior
chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.

- More than 2 weeks must have elapsed since previous radiation therapy and prior
radiation must be less than or equal to 15% of the bone marrow.

- Required Initial Laboratory Data: *ANC ≥ 1,500/mm3, *Platelet count ≥ 100,000/mm3,
*SGPT < 1.5 times ULN, *Alkaline phosphatase < 2.0 times ULN, *Bilirubin < 1.5 mg/dl,
*Serum creatinine < 1.5 times ULN

Exclusion Criteria:

- Pregnant or lactating women.

- Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina,
symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6
months, or uncontrolled arrhythmia.

- Phase 2 no previous or concurrent malignancy

- Central Nervous System (CNS) metastasis if neurologically unstable or requiring
steroid use.

- Active infection.

- Known positive HIV status.

- Conditions requiring use of H2 blockers or other antacids.

- Inability to provide informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Safety and determination of MTD, and recommended Phase 2 dose

Outcome Time Frame:

throughout study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

KTN22208

NCT ID:

NCT00097903

Start Date:

May 2004

Completion Date:

March 2012

Related Keywords:

  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Non-Small-Cell Lung
  • Solid Tumors
  • Oral
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

Ellis Fischel Cancer CenterColumbia, Missouri  65203