Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	OSU-0045 OSU-00HO224, NCI-2250, NCT00006929, 2250

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]).

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 28 days since prior cytotoxic chemotherapy and recovered

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy allowed except to indicator lesion

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Hemoglobin at least 9.0 g/dL
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 50 mL/min
• Calcium less than 11.5 mg/dL

Cardiovascular:

• No history of myocardial infarction within the past 6 months
• No history of congestive heart failure requiring therapy
• No history of unstable angina

Other:

• 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

Expected Enrollment

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.

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.

Villalona-Calero MA, Otterson GA, Wientjes MG, et al.: Noncytotoxic suramin as a chemosensitizer in patients with advanced non-small-cell lung cancer: a phase II study. Ann Oncol 19 (11): 1903-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

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

Miguel Villalona-Calero, MD, Protocol chair		Ph: 614-293-9424

Registry Information
Official Title		A Phase II Study Of Carboplatin/Paclitaxel/Suramin Chemotherapy In Non-Small Cell Lung Cancer(NSCLC)
Trial Start Date		2000-09-29
Registered in ClinicalTrials.gov		NCT00006929
Date Submitted to PDQ		2000-10-30
Information Last Verified		2004-04-27
NCI Grant/Contract Number		CA16058, CA76576

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