Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006929

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Drug: suramin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Carboplatin/Paclitaxel/Suramin Chemotherapy In Non-Small Cell Lung Cancer(NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Suramin Hexasodium Suramin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

September 2000

Detailed Description:

OBJECTIVES:

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).
Evaluate pharmacokinetic interactions of this drug combination in these patients (phase I). (Phase I closed to accrual 1/29/02).
Determine the objective response rate in patients treated with this regimen (phase II [chemotherapy-naive patients closed to accrual 9/1/03]).
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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/mm^3
Hemoglobin at least 9.0 g/dL
Platelet count at least 100,000/mm^3

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006929

Locations

United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240

Sponsors and Collaborators

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Miguel A. Villalona-Calero, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Villalona-Calero MA, Otterson GA, Wientjes MG, Weber F, Bekaii-Saab T, Young D, Murgo AJ, Jensen R, Yeh TK, Wei Y, Zhang Y, Eng C, Grever M, Au JL. Noncytotoxic suramin as a chemosensitizer in patients with advanced non-small-cell lung cancer: a phase II study. Ann Oncol. 2008 Nov;19(11):1903-9. Epub 2008 Jul 15.

Study ID Numbers:	CDR0000068345, OSU-0045, OSU-00HO224, NCI-2250
Study First Received:	December 6, 2000
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00006929 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiparasitic Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Antinematodal Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Mitosis Modulators
Suramin
Anthelmintics
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009