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Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00006929
Collaborator
(none)
82
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:

  1. Determine the minimum effective dose of suramin that will reduce resistance to chemotherapy with paclitaxel and carboplatin in patients with stage IIIB or IV non-small cell lung cancer (phase I). (Phase I closed to accrual 1/29/02).

  2. Evaluate pharmacokinetic interactions of this drug combination in these patients (phase I). (Phase I closed to accrual 1/29/02).

  3. Determine the objective response rate in patients treated with this regimen (phase II [chemotherapy-naive patients closed to accrual 9/1/03]).

  4. Determine the time to tumor progression, progression-free rate at 6 months, and 1-year survival of patients treated with this regimen (phase II [chemotherapy-naive patients closed to accrual 9/1/03]).

OUTLINE: Patients in phase II are stratified according to prior treatment (chemotherapy naive [closed to accrual 9/1/03] vs chemotherapy refractory). Phase I (phase I closed to accrual 1/29/02):

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.

Cohorts of 3-6 patients receive escalating doses of suramin until the target dose is determined. The target dose is defined as the dose at which at least 5 of 6 patients achieve optimal plasma concentrations of suramin and no more than 1 of 6 patients exceed optimal level. Doses of paclitaxel are adjusted until the maximum tolerated dose in combination with suramin and paclitaxel is determined.

Phase II (chemotherapy-naive patients closed to accrual 9/1/03): Patients receive the target dose of 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. Patients are followed every 3-6 weeks.

PROJECTED ACCRUAL: Approximately 82 patients (18 for phase I [phase I closed to accrual 1/29/02] and 64 for phase II [chemotherapy-naive patients closed to accrual 9/1/03]) will be accrued for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
Study Start Date :
Sep 1, 2000
Actual Primary Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (suramin, paclitaxel, carboplatin)

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: suramin
Given IV
Other Names:
  • 309 F
  • Antrypol
  • Bayer 205
  • Fourneau 309
  • Germanin

    • Drug: carboplatin
    Given IV
    Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

    • Drug: paclitaxel
    Given IV
    Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

    • Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentrations of suramin of 10-20 uM (Phase I) [Up to 72 hours]

    2. 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 Outcome Measures

    1. Progression-free survival according to RECIST (Phase II) [At 6 months]

    2. Survival (Phase II) [Up to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • Bilirubin no greater than 1.5 mg/dL

    • AST and ALT no greater than 2.5 times upper limit of normal

    • Creatinine no greater than 1.5 mg/dL

    • Creatinine clearance at least 50 mL/min

    • Calcium less than 11.5 mg/dL

    • No history of myocardial infarction within the past 6 months

    • No history of congestive heart failure requiring therapy

    • No history of unstable angina

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No active serious infection

    • HIV negative

    • No concurrent uncontrolled diabetes mellitus

    • No known hypersensitivity to Cremophor EL

    • No grade 2 or greater neuropathy

    • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

    • No known psychiatric condition that would preclude study compliance

    • At least 28 days since prior cytotoxic chemotherapy and recovered

    • Prior radiotherapy allowed except to indicator lesion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Miguel Villalona-Calero, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00006929
    Other Study ID Numbers:
    • NCI-2012-01403
    • OSU 0045
    • OSU-0045
    • OSU-00HO224
    • NCI-2250
    • CDR0000068345
    • U01CA076576
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 4, 2013
    Last Verified:
    Jun 1, 2013
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Suramin
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of Jun 4, 2013