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Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

Primary Purpose

Adenocarcinoma, Non-Small-Cell Lung Carcinoma, Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
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 Adenocarcinoma focused on measuring Motexafin Gadolinium, non-small cell, lung cancer, Lung cancer, cancer of the lung, Carcinoma, Non-Small-Cell Lung

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 NSCLC Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria ECOG performance status score of 0 or 1 Willing and able to provide written informed consent Exclusion Criteria: Laboratory values of: Absolute neutrophil count < 1500/ul; Platelet count < 75,000/ul; Hemoglobin < 10 gm/dl; AST or ALT > 3 x the upper limit of normal (ULN); Alkaline phosphatase > 5 x ULN; Bilirubin > 2 x ULN; Serum creatinine > 2.0 mg/dL. Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis. Evidence of meningeal metastasis. Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen). Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment. Significant weight loss > 10% of body weight in preceding 6 weeks. Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ. Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV. Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy). Known history of porphyria (testing not required at screening visit). Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit). Known history of HIV infection (testing not required at screening visit). Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential). Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection. Physical or mental condition that makes patient unable to complete specified follow-up assessments.

Sites / Locations

Outcomes

Primary Outcome Measures

To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC

Secondary Outcome Measures

To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients

Full Information

First Posted
August 10, 2005
Last Updated
August 19, 2008
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00129844
Brief Title
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
Official Title
Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
Detailed Description
Outline: Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms: Arm A - 10 mg/kg MGd once per week Arm B - 15 mg/kg MGd once every 3 weeks Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study. At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Non-Small-Cell Lung Carcinoma, Lung Neoplasms
Keywords
Motexafin Gadolinium, non-small cell, lung cancer, Lung cancer, cancer of the lung, Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium
Primary Outcome Measure Information:
Title
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
Secondary Outcome Measure Information:
Title
To select the most effective regimen based on tumor response
Title
To estimate the time to progression
Title
To estimate survival
Title
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients

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 NSCLC Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria ECOG performance status score of 0 or 1 Willing and able to provide written informed consent Exclusion Criteria: Laboratory values of: Absolute neutrophil count < 1500/ul; Platelet count < 75,000/ul; Hemoglobin < 10 gm/dl; AST or ALT > 3 x the upper limit of normal (ULN); Alkaline phosphatase > 5 x ULN; Bilirubin > 2 x ULN; Serum creatinine > 2.0 mg/dL. Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis. Evidence of meningeal metastasis. Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen). Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment. Significant weight loss > 10% of body weight in preceding 6 weeks. Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ. Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV. Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy). Known history of porphyria (testing not required at screening visit). Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit). Known history of HIV infection (testing not required at screening visit). Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential). Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection. Physical or mental condition that makes patient unable to complete specified follow-up assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Natale, M.D.
Organizational Affiliation
Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
Official's Role
Study Chair
Facility Information:
City
Fountain Valley
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Palm Springs
State/Province
California
Country
United States
City
Columbia
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

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