Clinical trial NCT00097903: Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer
Official title: Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Solid Tumors
Oral
Lead sponsor: BioNumerik Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Crown Bioscience
First posted: 2004-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Overall Safety and determination of MTD, and recommended Phase 2 dose
timeFrame: throughout study
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: various timepoints
measure: Tumor response
timeFrame: various timepoints
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
Study officials:
References: