Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI UTHSC-9785011153 SACI-IDD-97-27, NCI-T97-0091, NCT00003721, T97-0091

Objectives

I. Define the maximum tolerated dose of COL-3 in patients with advanced solid 
tumors.

II. Identify the dose limiting toxicity and safety profile of COL-3 in these 
patients.

III. Define the pharmacokinetics and pharmacodynamics of COL-3 in these 
patients.

IV. Observe any evidence of antitumor activity through standard response 
criteria or biologic surrogate markers.

Entry Criteria

Disease Characteristics:

Histologically or cytopathologically proven advanced solid tumors for which no
conventional therapy exists or that is refractory to standard therapy

No primary brain tumors or active brain metastases, including known evidence
of cerebral edema by CT or MRI, known tumor progression from prior imaging
studies or clinical symptoms of/from brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 At least 4 weeks since chemotherapy
 At least 6 weeks since nitrosoureas or mitomycin
 At least 3 months since suramin  

Endocrine therapy:
 No concurrent steroids
     
Radiotherapy:
 At least 4 weeks since prior large field radiation therapy (greater than 20%  
  of total bone marrow) 

Surgery:
 At least 14 days since major surgery
 No major upper gastrointestinal surgery

Other:
 No concurrent anticonvulsant medications

Patient Characteristics:

Age:
 18 and over  

Performance status:
 ECOG 0-2  

Life expectancy:
 Greater than 12 weeks

Hematopoietic:
 Absolute neutrophil count greater than 1,500/mm3
 Platelet count greater than 100,000/mm3
 Hemoglobin greater than 9 g/dL
 
Hepatic:
 Bilirubin normal 
 PT or PTT normal
 ALT or AST less than 2.5 times upper limit of normal

Renal:
 Creatinine less than 1.5 mg/dL OR
 Creatinine clearance greater than 60 mL/min

Cardiovascular:
 No myocardial infarction, stroke, or congestive heart failure within 3 months

Other:
 HIV negative
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception
 No history of gastrointestinal disorders that interfere with absorption       
  of COL-3
 No active infections or other medical illnesses
 No psychological or social problems
 No emotional disorder or substance abuse
 No hypersensitivity to tetracycline or its derivative

 

Expected Enrollment

Up to 30 patients will be accrued within 1 year for this study.

Outline

This is a dose escalation study.

Patients receive oral COL-3 once daily. Treatment continues in the absence of 
disease progression and unacceptable toxic effects.

Cohorts of 3-6 patients each receive escalating doses of COL-3.  Dose
escalation to the next level occurs after 3 patients have completed 28 days of
treatment without dose limiting toxicity (DLT).  Dose escalation continues
until the maximum tolerated dose (MTD) is determined.  The MTD is defined as
the dose preceding that at which 2 or more of 6 patients experience DLT.

Trial Contact Information

Trial Lead Organizations

San Antonio Cancer Institute

Eric Rowinsky, MD, Protocol chair		Ph: 210-616-5798 Email: erowinsk@idd.org

Registry Information
Official Title		A Phase I, Pharmacologic and Biologic Study of Col-3 (NSC683551) Administered on a 28-Day Oral Dosing Schedule in Patients with Advanced Solid Tumors
Trial Start Date		1999-01-15
Registered in ClinicalTrials.gov		NCT00003721
Date Submitted to PDQ		1998-12-23
Information Last Verified		2002-04-01
NCI Grant/Contract Number		P30-CA54174, U01-CA69853