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A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)


PRIMARY OBJECTIVES:

I. 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).

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

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

IV. 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 72 hours

Safety Issue:

No

Principal Investigator

Miguel Villalona-Calero

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01403

NCT ID:

NCT00006929

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240