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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Primary Purpose

Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Lung Cancer, Breast Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Metastatic Cancer, Advanced Cancer, Genitourinary Cancer, Glioblastoma Multiforme, Recurrent Cancer, Colon Cancer, Gastric Cancer, Stomach Cancer, Pancreatic Cancer, Esophageal Cancer, Throat Cancer, Bladder Cancer, Kidney Cancer, Renal Cancer, Cervical Cancer, Endometrial Cancer, Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of Pittsburgh Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2005
Last Updated
April 2, 2009
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00120939
Brief Title
Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
Official Title
Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
Keywords
Lung Cancer, Breast Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Metastatic Cancer, Advanced Cancer, Genitourinary Cancer, Glioblastoma Multiforme, Recurrent Cancer, Colon Cancer, Gastric Cancer, Stomach Cancer, Pancreatic Cancer, Esophageal Cancer, Throat Cancer, Bladder Cancer, Kidney Cancer, Renal Cancer, Cervical Cancer, Endometrial Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium
Primary Outcome Measure Information:
Title
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
Secondary Outcome Measure Information:
Title
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurkamal Chatta, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

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