Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00373204
• Other study ID #: PCYC-0229
• Status: Terminated
• Phase: Phase 2
• First received: September 5, 2006
• Last updated: July 23, 2014
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: July 2014
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.

Description:

Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• Histologically or cytologically confirmed diagnosis of NSCLC

• Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen

• Measurable disease per RECIST

• ECOG performance status score of 0 or 1

• Willing and able to provide written informed consent

Exclusion Criteria:

• Laboratory values of: ANC < 1500/mm³, Platelet count < 100,000/mm³, hemoglobin < 10 g/dL, AST or ALT > 2.5 x upper limit of normal (ULN), Alkaline phosphatase > 5 x ULN, bilirubin > 1.5 x ULN, serum creatinine > 2.0 mg/dL (176 umol/dL), albumin < 3.0 g/dL (30 g/L)

• Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases

• Evidence of meningeal metastasis

• > 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen, or prior MGd)

• 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 within preceding 6 weeks

• Treatment for another cancer within 3 years before enrollment, except basal cell carcinoma of the skin or cervical cancer in situ

• Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association 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)

• History of hypersensitivity to taxanes or polysorbate 80

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Motexafin Gadolinium
On Day 1 of each 3 week cycle for up to 12 cycles: MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed = 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.

Locations

Country	Name	City	State
Canada	Hospital Charles Lemoyne	Greenfield Park	Quebec
Canada	Cancer Centre of Southeastern Ontario	Kingston	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Russian Federation	Chelyabinsk Regional Oncology Dispensary	Chelyabinsk
Russian Federation	Blokhin Cancer Research Center (Dept. of Chemotherapy)	Moscow
Russian Federation	Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)	Moscow
Russian Federation	Central Clinical Hospital	Moscow
Russian Federation	Moscow Oncology Hospital #62	Moscow
Russian Federation	Samara Regional Oncology Center	Samara
Russian Federation	St. Petersburg City Oncology Center	St. Petersburg
Russian Federation	Regional Oncology Dispensary	Yaroslavl
Serbia	Clinic for Pulmonary Diseases	Belgrade
Serbia	Clinic for Pulmonary Diseases, Military Medical Academy	Belgrade
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Institute for Pulmonary Diseases of Vojvodina	Sremska Kamenica
United States	Tri-County Hematology & Oncology Associates	Canton	Ohio
United States	Cancer Specialists of Tidewater	Chesapeake	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Wilshire Oncology Medical Group	La Verne	California
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel	The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.	up to 12 cycles	No
Secondary	To estimate the time of progression	The progression is defined as the time fromfirst does of MGd to first eviedence of progression	up to 12 cycles	Yes
Secondary	To estimate overall survival	The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel	up to 12 cycles	Yes
Secondary	To estimate progression-free survival	Progression-free survival is defined as the time from first does of MGd to the earlier of progression	up to 12 cycles	Yes
Secondary	To estimate duration of response (CR + PR)	Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.	Up to 12 cycles	Yes
Secondary	To estimate clinical benefit rate (CR + PR + stable disease [SD])	The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation	up to 12 cycles	Yes
Secondary	To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC	All patients who receive at one dose of MGd will be included in the safety summaries and analyses	Up to 12 cycles	Yes