Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Pharmacyclics
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00365183
First received: August 15, 2006
Last updated: May 13, 2013
Last verified: May 2012
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Purpose
The goals of this study are:
- to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
- to assess response to treatment in patients with NSCLC six months after beginning study treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Carcinoma |
Drug: Motexafin gadolinium and pemetrexed |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- 6 month progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
Secondary Outcome Measures:
- Time to disease progression [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Time to progression is defined as the time from first dose of MGd to first evidence of progression.
- Overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
- Progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
- Response rate (CR+PR) by RECIST criteria [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
- Duaration of reponse (CR+PR) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
- Clinical benefit rate (CR+PR+SD) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
- Safety and tolerability of MGd and pemetrexed [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]All patients who receive any MGd will be included in the safety summaries and analyses
| Enrollment: | 74 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xcytrin® (motexafin gadolinium) |
Drug: Motexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Other Name: MGd and Alimta®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older
- Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
- ECOG performance status score of 0 or 1
Exclusion Criteria:
- Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
- Symptomatic or uncontrolled brain metastases
- Evidence of meningeal metastasis
- > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
- Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365183
Locations
| United States, California | |
| Huntington Beach, California, United States | |
| Long Beach, California, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| Santa Fe, New Mexico, United States | |
| United States, New York | |
| Armonk, New York, United States | |
| United States, Ohio | |
| Columbus, Ohio, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Study Chair: | Martin Edelman, MD | University of Maryland, Greenbaum Cancer Center |
More Information
Publications:
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00365183 History of Changes |
| Other Study ID Numbers: | PCYC-0228 |
| Study First Received: | August 15, 2006 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
Non Small Cell Lung Cancer Lung Cancer Metastatic Lung Cancer Inoperable Lung Cancer Advanced Lung Cancer Large Cell Lung Cancer Adenocarcinoma, lung |
Squamous Cell Carcinoma, lung Squamous Cell Lung Cancer Large Cell Carcinoma, lung Cancer of the Lung Carcinoma Bronchogenic |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Pemetrexed |
Motexafin gadolinium Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013