NCT00003768

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced solid tumors that have not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1998

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

April 6, 2000

Last Update Submit

January 6, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

fosbretabulin disodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced solid tumors that have failed standard therapy or for which no curative therapy exists No leukemia, lymphoma, or multiple myeloma No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT/SGPT no greater than 3 times upper limit of normal (ULN) PT/PTT less than ULN OR International normalized ratio (INR) less than 1.1 Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clear evidence of acute ischemic heart disease on EKG No history of myocardial infarction within past 6 months No history of angina No peripheral vascular disorder Neurologic: No active seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of hematemesis, melena, or hematochezia No history of inflammatory bowel disease, autoimmune disease, or bleeding disorders No Type I diabetes mellitus or Type II diabetes with peripheral vascular disorders No active infections or any serious concurrent systemic disorders incompatible with study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 6 weeks since prior major surgery Other: At least 4 weeks since any other prior investigational agent No concurrent anticonvulsant therapy No concurrent aspirin greater than 100 mg per day, heparin, or nonsteroidal antiinflammatory medication No concurrent calcium channel blockers, antiarrhythmias, or anti-angina therapy Concurrent beta-blocking agents for hypertension or anxiety allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

  • Giri P, Batra PJ, Kumari A, Hura N, Adhikary R, Acharya A, Guchhait SK, Panda D. Development of QTMP: A promising anticancer agent through NP-Privileged Motif-Driven structural modulation. Bioorg Med Chem. 2023 Nov 15;95:117489. doi: 10.1016/j.bmc.2023.117489. Epub 2023 Oct 5.

    PMID: 37816266DERIVED

MeSH Terms

Interventions

fosbretabulin

Study Officials

  • Scot C. Remick, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

May 3, 2004

Study Start

September 1, 1998

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)