Trial record 8 of 71301 for:
pharmacology
Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma
This study is currently recruiting participants.
Verified February 2013 by New Mexico Cancer Care Alliance
Sponsor:
New Mexico Cancer Care Alliance
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00947739
First received: July 24, 2009
Last updated: February 18, 2013
Last verified: February 2013
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Purpose
This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients with Solid Tumors or Lymphoma.
OBJECTIVES
Primary:
- To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.
To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.
Secondary:
- To perform a pharmacokinetic study of orally administered CZ48 in the plasma.
- To assess responses by RECIST criteria.
- To follow patients for survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Lymphomas |
Drug: Camptothecin-20-O-Propionate Hydrate (CZ48) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma |
Resource links provided by NLM:
Further study details as provided by New Mexico Cancer Care Alliance:
Primary Outcome Measures:
- To describe the dose limiting toxicities, adverse event profile, and Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48). [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To perform a pharmacokinetic study of orally administered CZ48 in the plasma. To assess responses by RECIST criteria and to follow patients for survival. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
80 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48)PO, DAILY
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 2
160 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 3
320 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 4
640 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 5a
1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, DAILY
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 6
2560 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 7
18 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 8
36 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 9
72 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 10
144 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 11
288 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 12
576 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 13
750mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 14
1000mg/m2 PO Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
|
Experimental: Cohort 5b
1280 mg/m2 Camptothecin-20-O-Propionate Hydrate (CZ48) PO, TID
|
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.
Other Name: CZ48
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients, 18 years of age or older, with incurable advanced solid tumors or lymphomas are eligible.
- Patients must have a Zubrod performance status of 0-1.
- Patients must sign an informed consent document.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 -along with an absence of a red blood cell transfusion in the two weeks prior to their participation in the trial.
- Patients should have adequate hepatic function with a total bilirubin within normal range and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine within the upper limit of normal.
- Patients may receive no other concurrent anticancer treatments such as chemotherapy, hormonotherapy (except for prostate cancer patients on LHRH agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception (contraceptive pill, or IUD, or two mechanical barriers).
- Patients with severe uncontrolled medical problems are not eligible for this trial.
- Patients who have too much esterase activity in the blood, with a conversion rate yielding concentration of CPT > 20 ng/ml in vitro. Please see section 6.5 for sample collection, preparation and shipping. A validated analysis will be performed according to Sponsor SOP SFCR.PH.R.01.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947739
Contacts
| Contact: Valerie Parks, BSN | 505-925-0390 | vparks@salud.unm.edu |
Locations
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Valerie Parks, BSN 505-925-0390 vparks@salud.unm.edu | |
| Principal Investigator: Montasur Shaheen, M.D. | |
| United States, Texas | |
| University of Texas Health Sciences Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Mahalingam, MD | |
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
| Principal Investigator: | Monte Shaheen, M.D. | University of New Mexico Cancer Center |
More Information
No publications provided
| Responsible Party: | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT00947739 History of Changes |
| Other Study ID Numbers: | INST CZ48-01, NCI-2011-02688 |
| Study First Received: | July 24, 2009 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Mexico Cancer Care Alliance:
|
CZ Stehlin Lymphomas |
Additional relevant MeSH terms:
|
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lymphoma Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Camptothecin Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013