Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-16

Brief Summary

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The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

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Detailed Description

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The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Conditions

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Carcinoma, Non Small Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

IV over 60 minutes, 75 mg/m2

Docetaxel plus Suramin

Group Type EXPERIMENTAL

Suramin

Intervention Type DRUG

IV over 30 minutes

Docetaxel

Intervention Type DRUG

IV over 60 minutes. 56 mg/m2

Interventions

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Docetaxel

IV over 60 minutes, 75 mg/m2

Intervention Type DRUG

Suramin

IV over 30 minutes

Intervention Type DRUG

Docetaxel

IV over 60 minutes. 56 mg/m2

Intervention Type DRUG

Other Intervention Names

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Taxotere Taxotere

Eligibility Criteria

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Inclusion Criteria

* Pathologically proven diagnosis of non-small cell lung cancer
* Documented disease progression after first-line chemotherapy for non-small cell lung cancer
* Stable and treated CNS metastasis is allowed
* Radiation must be completed at least 2 weeks prior to starting protocol treatment
* Major surgery must be completed at least 4 weeks prior to starting protocol treatment
* ECOG performance status 0-2
* Sexually active patients must use adequate contraception
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function

Exclusion Criteria

* Severe hypersensitivity reaction to docetaxel
* Pre-existing grade 3 or 4 neuropathy
* Women who are pregnant or breastfeeding
* Uncontrolled intercurrent illness
* Receipt of 3 or more prior chemotherapy regimens

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No