NCT00080041

Brief Summary

The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

May 15, 2007

Status Verified

May 1, 2007

First QC Date

March 22, 2004

Last Update Submit

May 11, 2007

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung Neoplasms

Keywords

Antineoplastic Combined Chemotherapy Protocols

Outcome Measures

Primary Outcomes (1)

  • Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).

Secondary Outcomes (1)

  • Frequency of tumor responses at weeks 6, 12 and 18.

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma)
  • ECOG performance status score either 0 or 1
  • Willing and able to provide written informed consent

You may not qualify if:

  • Laboratory Values of:
  • Absolute neutrophil count \< 2000/µL
  • Platelet count \< 100,00/µL
  • AST or ALT \> 1.5 x the upper limit of normal
  • Alkaline phosphatase \> 5 x the upper limit of normal
  • Bilirubin \> ULN
  • Creatinine \> 2.0 mg/dL
  • and
  • Peripheral neuropathy NCI CTC Grade 3 or higher
  • Chemotherapy, radiation therapy, immunotherapy, or systemic biologic
  • anticancer therapy within 21 days before beginning study treatment
  • Known history of brain metastases or spinal cord compression
  • Uncontrolled hypertension
  • Myocardial infarction within 6 months before beginning study treatment
  • Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Cancer Center

Rochester, New York, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung Neoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2004

First Posted

March 23, 2004

Last Updated

May 15, 2007

Record last verified: 2007-05

Locations

US(1)