NCT00120939

Brief Summary

The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.

Trial Health

80
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

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

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

April 3, 2009

Status Verified

May 1, 2007

First QC Date

July 12, 2005

Last Update Submit

April 2, 2009

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung NeoplasmsGastrointestinal Neoplasms

Keywords

Lung CancerBreast CancerProstate CancerOvarian CancerHead and Neck CancerGastrointestinal CancerMetastatic CancerAdvanced CancerGenitourinary CancerGlioblastoma MultiformeRecurrent CancerColon CancerGastric CancerStomach CancerPancreatic CancerEsophageal CancerThroat CancerBladder CancerKidney CancerRenal CancerCervical CancerEndometrial CancerColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Outcomes (1)

  • Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

Interventions

Motexafin GadoliniumDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old
  • Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
  • ECOG performance status score either 0, 1, or 2
  • Willing and able to provide written informed consent

You may not qualify if:

  • Greater than two prior cytotoxic regimens
  • Laboratory values showing adequate function of bone marrow, liver, and kidneys
  • Uncontrolled hypertension
  • Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsProstatic NeoplasmsLung NeoplasmsGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasm MetastasisUrogenital NeoplasmsGlioblastomaRecurrenceColonic NeoplasmsStomach NeoplasmsPancreatic NeoplasmsEsophageal NeoplasmsUrinary Bladder NeoplasmsKidney NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsColorectal 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, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueDisease AttributesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesStomach DiseasesPancreatic DiseasesEsophageal DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesKidney DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesRectal Diseases

Study Officials

  • Gurkamal Chatta, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

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

July 12, 2005

First Posted

July 19, 2005

Last Updated

April 3, 2009

Record last verified: 2007-05

Locations

US(1)