A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma Carcinoma, Bronchogenic

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Motexafin Gadolinium Injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No