NCT00006929

Brief Summary

Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

7.2 years

First QC Date

December 6, 2000

Last Update Submit

June 3, 2013

Conditions

Recurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Plasma concentrations of suramin of 10-20 uM (Phase I)

    Up to 72 hours

  • Objective response rate (complete response [CR] and partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

    Up to 4 years

Secondary Outcomes (2)

  • Progression-free survival according to RECIST (Phase II)

    At 6 months

  • Survival (Phase II)

    Up to 1 year

Study Arms (1)

Treatment (suramin, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive suramin IV over 30 minutes on days 1 and 2. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: suraminDrug: carboplatinDrug: paclitaxelOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

suraminDRUG

Given IV

Also known as: 309 F, Antrypol, Bayer 205, Fourneau 309, Germanin
Treatment (suramin, paclitaxel, carboplatin)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (suramin, paclitaxel, carboplatin)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (suramin, paclitaxel, carboplatin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (suramin, paclitaxel, carboplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (suramin, paclitaxel, carboplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced non-small cell lung cancer
  • Stage IIIB not amenable to concurrent chemotherapy or radiotherapy (e.g., pleural effusion or low pulmonary reserve)
  • Stage IV
  • Measurable disease
  • Meets criteria for 1 of the following:
  • Chemotherapy naive (phases I and II) (phase I closed to accrual 1/29/02) (phase II \[chemotherapy-naive patients\] closed to accrual 9/1/03)
  • Previously treated (phase I) (phase I closed to accrual 1/29/02)
  • Received no more than 1 prior chemotherapy regimen
  • Chemotherapy refractory, defined as disease progression during or within 3 months after carboplatin/paclitaxel chemotherapy (phase II)
  • No known brain or leptomeningeal disease unless previously irradiated, currently not undergoing corticosteroid therapy, and clinically asymptomatic
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Hemoglobin at least 9.0 g/dL
  • Platelet count at least 100,000/mm\^3
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SuraminCarboplatinPaclitaxelTaxes

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic CompoundsCoordination ComplexesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesEconomicsHealth Care Economics and Organizations

Study Officials

  • Miguel Villalona-Calero

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2000

First Posted

January 27, 2003

Study Start

September 1, 2000

Primary Completion

November 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)