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Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

Primary Purpose

Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium Injection
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 Antineoplastic Combined Chemotherapy Protocols

Eligibility Criteria

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

Inclusion Criteria: ≥ 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 Exclusion Criteria: 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 Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80 Known history of porphyria (testing not required at screening) Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening) Known history of HIV infection (testing not required at screening) Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection Physical or mental condition that makes patient unable to complete specified follow-up assessments

Sites / Locations

  • University of Rochester Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2004
Last Updated
May 11, 2007
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00080041
Brief Title
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
Official Title
Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Administered at 3-Week Intervals for 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, 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.

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
Keywords
Antineoplastic Combined Chemotherapy Protocols

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium Injection
Primary Outcome Measure Information:
Title
Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).
Secondary Outcome Measure Information:
Title
Frequency of tumor responses at weeks 6, 12 and 18.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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 Exclusion Criteria: 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 Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80 Known history of porphyria (testing not required at screening) Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening) Known history of HIV infection (testing not required at screening) Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection Physical or mental condition that makes patient unable to complete specified follow-up assessments
Facility Information:
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

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