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Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma

NCT00947739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-06-18

No results posted yet for this study

Summary

This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients with Solid Tumors or Lymphoma.

OBJECTIVES

Primary:

1. To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.
2. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.

Secondary:
3. To perform a pharmacokinetic study of orally administered CZ48 in the plasma.
4. To assess responses by RECIST criteria.
5. To follow patients for survival.

Conditions

Interventions

DRUG

Camptothecin-20-O-Propionate Hydrate (CZ48)

CZ48 will be administered in successive cohorts of 1 patient per participating site until hints of toxicity (grade 2 or worse adverse events related to the drug) are observed. Then cohort of 3+3 patients will be treated. CZ48 will be administered orally daily for 3 weeks followed by a 1 week rest. (1 course = 4 weeks). No pre-medications will be administered. Patients will be asked to drink 2 liters of fluid daily to flush the bladder.

Sponsors & Collaborators

  • Christus Stehlin Foundation for Cancer Research

    collaborator UNKNOWN

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Monte Shaheen, M.D. · University of New Mexico Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-12-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947739 on ClinicalTrials.gov