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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00373204
• Date of registration: 05/09/2006
• Prospective Registration: No
• Primary sponsor: Pharmacyclics
• Public title: Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
• Scientific title: Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
• Date of first enrolment: May 2006
• Target sample size: 50
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00373204
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, Former Serbia and Montenegro, Russian Federation, Serbia, United States

Contacts

• Name: Kishan Pandya, MD
• Affiliation: University of Rochester, Rochester, NY, USA

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: Motexafin Gadolinium

Primary Outcome(s)

To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel [Time Frame: up to 12 cycles]

Secondary Outcome(s)

To estimate clinical benefit rate (CR + PR + stable disease [SD]) [Time Frame: up to 12 cycles]

To estimate the time of progression [Time Frame: up to 12 cycles]

To estimate duration of response (CR + PR) [Time Frame: Up to 12 cycles]

To estimate progression-free survival [Time Frame: up to 12 cycles]

To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC [Time Frame: Up to 12 cycles]

To estimate overall survival [Time Frame: up to 12 cycles]

Secondary ID(s)

PCYC-0229

Source(s) of Monetary Support

Please refer to primary and secondary sponsors