Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00102505
Other study ID # PCYC-0220
Secondary ID
Status Completed
Phase Phase 1
First received January 29, 2005
Last updated April 2, 2009
Start date November 2004

Study information

Verified date April 2009
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 the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years old

- ECOG score of 0, 1, or 2

- Histologically confirmed diagnosis of non-small cell lung cancer

Exclusion Criteria:

Laboratory values demonstrating inadequate function of the following:

- Bone marrow

- Kidneys

- Liver

and

- Peripheral neuropathy Grade 2 or higher

- Greater than 2 prior chemotherapy regimens

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Motexafin Gadolinium Injection


Locations

Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Primary Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Secondary Tumor response
See also
  Status Clinical Trial Phase
Completed NCT00985855 - Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer Phase 2
Completed NCT01048645 - Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00098085 - Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04995523 - A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC Phase 1/Phase 2
Completed NCT00910676 - Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors Phase 2
Withdrawn NCT00108186 - Celecoxib Treatment for Lung Cancer Phase 1
Recruiting NCT05037825 - The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Recruiting NCT00379717 - Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00404924 - ZD6474 (ZACTIMAâ„¢) Phase III Study in EGFR Failures Phase 3
Recruiting NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Phase 2
Active, not recruiting NCT03088540 - Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Phase 3
Terminated NCT00232206 - Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer Phase 2
Terminated NCT00271323 - Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients Phase 2
Completed NCT00037817 - Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies Phase 1
Completed NCT03444766 - Study of Nivolumab for Advanced Cancers in India Phase 4
Completed NCT04351334 - Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Active, not recruiting NCT02416739 - Anticancer Activity of Nicotinamide on Lung Cancer Phase 2/Phase 3
Completed NCT00444015 - Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC) Phase 1
Completed NCT00105092 - Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer. Phase 2