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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non Small Cell Lung

Treatments: Drug: Suramin; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01671332

2012-0118 (Other Identifier)

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

A534260 (Other Identifier)

NCI-2012-01113 (Registry Identifier)

CO11508

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Docetaxel

Active Comparator group

Treatment:

Drug: Docetaxel

Drug: Docetaxel

Docetaxel plus Suramin

Experimental group

Treatment:

Drug: Docetaxel

Drug: Suramin

Drug: Docetaxel