Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
This study has been completed.
Sponsor:
Pharmacyclics
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00373204
First received: September 5, 2006
Last updated: May 13, 2013
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Motexafin Gadolinium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
Secondary Outcome Measures:
- To estimate the time to progression. [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]to progression is defined as the time from first dose of MGd to first evidence of progression.
- To estimate overall survival. [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel.
- To estimate progression-free survival. [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]Progression-free survival is defined as the time from first dose of MGd to the earlier of progression
- To estimate duration of response (CR + PR) [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]Duration of response (CR+PR) is defined as the time from the first response to the time of disease progression.
- To estimate clinical benefit rate (CR + PR + stable disease [SD]) [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation
- To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]all patients who receive at one dose of MGd will be included in the safety summaries and analyses
| Enrollment: | 50 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xcytrin® (motexafin gadolinium) |
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. Other Name: MGd and Docetaxtel
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373204
Locations
| United States, California | |
| Wilshire Oncology Medical Group | |
| La Verne, California, United States | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States | |
| United States, Ohio | |
| Tri-County Hematology & Oncology Associates | |
| Canton, Ohio, United States | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States | |
| United States, Virginia | |
| Cancer Specialists of Tidewater | |
| Chesapeake, Virginia, United States | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario | |
| Kingston, Ontario, Canada | |
| Canada, Quebec | |
| Hospital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada | |
| Russian Federation | |
| Chelyabinsk Regional Oncology Dispensary | |
| Chelyabinsk, Russian Federation | |
| Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy) | |
| Moscow, Russian Federation | |
| Moscow Oncology Hospital #62 | |
| Moscow, Russian Federation | |
| Blokhin Cancer Research Center (Dept. of Chemotherapy) | |
| Moscow, Russian Federation | |
| Central Clinical Hospital | |
| Moscow, Russian Federation | |
| Samara Regional Oncology Center | |
| Samara, Russian Federation | |
| St. Petersburg City Oncology Center | |
| St. Petersburg, Russian Federation | |
| Regional Oncology Dispensary | |
| Yaroslavl, Russian Federation | |
| Serbia | |
| Institute for Oncology and Radiology of Serbia | |
| Belgrade, Serbia | |
| Clinic for Pulmonary Diseases, Military Medical Academy | |
| Belgrade, Serbia | |
| Clinic for Pulmonary Diseases | |
| Belgrade, Serbia | |
| Institute for Pulmonary Diseases of Vojvodina | |
| Sremska Kamenica, Serbia | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Study Chair: | Kishan Pandya, MD | University of Rochester, Rochester, NY, USA |
More Information
No publications provided
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00373204 History of Changes |
| Other Study ID Numbers: | PCYC-0229 |
| Study First Received: | September 5, 2006 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
Advanced non-small cell lung cancer Non-small cell lung cancer Lung cancer Metastatic lung cancer |
Second line treatment for advanced lung cancer Cancer Advanced lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Docetaxel Motexafin gadolinium Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013