The Physician Data Query Protocol File (PDQP) contains information on over 1400 active and approved cancer treatment protocols. All clinical trials directly supported by the National Cancer Institute (NCI), as well as those voluntarily submitted by other investigators, are included. Protocols with a status of "active" are open to patient entry. "Approved" protocols have been approved by the NCI or other administrative body, but have not yet begun to enter patients. Documents contain detailed information such as protocol objectives, patient entry criteria, details of the treatment regimen, dosage modification, and participating organizations.
The following alphabetical list provides the two-letter label, the relevant alias, and an example for each PDQ Protocol File database field.
===== ============ Label Name/Example ===== ============ ab Abstract [Word Indexed] example: neuropsychiatric.ab. an Accession Number [Word and Phrase Indexed] example 1: 010652.an. example 2: pdqp-010542.an. cn Cancer Name [Word Indexed] example: small cell lung.cn. di Drug Identifiers [Word Indexed] example: arabinoside.di. id Identification Number [Phrase Indexed] example: clb-9362.id. lo Lead Organizations [Word Indexed] example 1: ohio.lo. example 2: herbert maurer.lo. ph Phase [Word Indexed] example: phase iii.ph. po Participating Organizations [Word Indexed] example: roswell park.po. pr Protocol Name [Word Indexed] example: small cell lung.pr. ps Protocol Status [Word Indexed] example 1: "930528".ps. example 2: "93$4".ps. tm Therapy Modality [Word Indexed] example: radiation therapy.tm. tx Detail of Protocol [Word Indexed] example: randomized study.tx. ty Type of Protocol [Word Indexed] example: clinical trial.ty. up Update Code [Phrase Indexed] example: 9703.up.
Childhood Cancers Sentence Syntax: limit 1 to childhood cancers
Command Syntax: ..c/pdqp Sentence Syntax: use pdqp
[Active Protocol: Currently Accepting New Patients]
Accession Number
PDQP-010652
Update Code
9703
Cancer Name
Adult HD
HD, adult
Hodgkin's disease, adult
Hodgkin's lymphoma, adult
Lymphoma, Hodgkin's, adult
Lymphoma, non-Hodgkin's, adult
NHL, adult
Non-Hodgkin's lymphoma, adult
Adult HD, recurrent
Adult HD, relapsed
Adult Hodgkin's disease, recurrent
Adult Hodgkin's disease, relapsed
HD, adult, recurrent
HD, adult, relapsed
HD, recurrent, adult
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Identification Number
FCCC-96004
NCI-T95-0075H
Protocol Name
Phase I Study of Topotecan/Paclitaxel/Carboplatin with and without
G-CSF for Advanced Solid Tumors or Lymphomas Refractory to Standard
Therapy (Summary Last Modified 09/96).
Protocol Status
Date Activated: 960729
Date Temporarily Closed: 961001.
Type of Protocol
treatment clinical trial.
Phase
Phase I study.
Therapy Modality
Chemotherapy
Hematologic toxicity attenuation
Supportive care/therapy.
Drug Identifiers
Carboplatin
Carboplatin/granulocyte colony-stimulating
factor/paclitaxel/topotecan
Carboplatin/paclitaxel/topotecan
Granulocyte colony-stimulating factor
Paclitaxel
Topotecan
Carboplatin. Carboplat. JM-8. Paraplat. Paraplatin. Paraplatine.
Carboplatin/granulocyte colony-stimulating
factor/paclitaxel/topotecan. CBDCA/G-CSF/TAX/TOPO.
Carboplatin/paclitaxel/topotecan. CBDCA/TAX/TOPO.
Granulocyte colony-stimulating factor. Colony stimulating factor,
granulocyte. Filgrastim. G CSF. Granulocyte colony stimulating
factor. Lenograstim. Neupogen.
Paclitaxel. Taxol.
Topotecan. Hycamptamine. Hycamtin. SK&F 104864. SKF 104864..
Abstract
OBJECTIVES:
I. Estimate the maximum tolerated doses of
topotecan/paclitaxel/carboplatin (TOPO/TAX/CBDCA) with and without
granulocyte colony-stimulating factor in patients with advanced
solid tumors or lymphomas.
II. Describe the toxicity of this regimen.
III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether
TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as
compared to TOPO administered alone on day 5.
IV. Describe any clinical responses observed in these patients.
V. Determine topoisomerase I enzyme activity, mRNA expression, and
protein content, when feasible, in accessible tumor tissues and in
peripheral mononuclear cells, and determine whether these parameters
correlate with response and toxicity.
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Detail of Protocol
WARNING:
Many protocols are potentially hazardous, are intended only for use
by clinical oncologists in carefully structured settings, and may
not prove to be more effective than standard treatment. A
responsible investigator associated with this protocol should be
consulted before using this protocol. Dose and schedule
modifications are required for patients who develop
gastrointestinal, hematologic, neurologic, and biochemical (renal,
hepatic, etc.) and/or other abnormalities after the administration
of therapy. Additionally, Federal regulations for the protection of
human subjects require approval of clinical trials by your local
Institutional Review Board.
PROTOCOL OUTLINE:
The MTD of TOPO/TAX/CBDCA is determined without G-CSF in Part I, and
with G-CSF in Part II.
The following acronyms are used:
CBDCA Carboplatin, NSC-241240
G-CSF Granulocyte Colony-Stimulating Factor, NSC-614629
TAX Paclitaxel, NSC-125973
TOPO Topotecan, NSC-609699
3-Drug Combination Chemotherapy with and without Hematologic Toxicity
Attenuation. TOPO/TAX/CBDCA; with and without G-CSF.
-sample truncated-
Lead Organizations
Lead Organization:
Fox Chase Cancer Center
Local ID Number:
FCCC-96004
Chairmen:
Corey Jay Langer
215-728-2985, 215-728-2687.
Some material in the PDQ database is from copyrighted publications of the respective copyright claimants. Users of the database are referred to the publication data appearing in the bibliographic citations, as well as to the copyright notices appearing in the original publication, all of which are hereby incorporated by reference. The NCI represents that PDQ is formulated with a reasonable standard of care. Except for this representation, NCI makes no representations or warranties, express or implied, including any implied warranty of merchantability or fitness for a particular purpose, with respect to PDQ. The documents contained in PDQ may be retained for personal or educational use only. Information should not be edited or modified. Any resale or redistribution of all or portions of the information is not permitted.
Because use of the PDQ database for insurance reimbursement decisions is contrary to the nature of the database, which is designed as a research tool and not to reflect all possible treatment options, customers agree to not make the database available to users who wish to use it for reimbursement decision purposes.
Revised 7 July, 1998