Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory 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:	NCT00066768

Purpose

RATIONALE: Drugs used in chemotherapy such as docetaxel and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel or gemcitabine may reduce resistance to the drugs and kill more tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of suramin when given together with either docetaxel or gemcitabine in treating patients with stage IIIB or stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).

Condition	Intervention	Phase
Lung Cancer	Drug: docetaxel Drug: gemcitabine hydrochloride Drug: suramin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Pilot Study of Low Dose Suramin As Modulator Of Docetaxel And Gemcitabine In Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Docetaxel Gemcitabine hydrochloride Suramin Hexasodium Suramin

U.S. FDA Resources

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

Study Start Date:

July 2003

Detailed Description:

OBJECTIVES:

Determine the safety of low-dose suramin administered with docetaxel or gemcitabine in patients with stage IIIB or IV platinum-refractory non-small cell lung cancer.
Determine, preliminarily, the antitumor activity of these regimens in these patients.
Determine whether suramin plasma concentrations in combination with docetaxel or gemcitabine can be predicted by pretreatment dose calculations based on clinical parameters.

OUTLINE: This is a randomized, pilot, dose-finding study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
Arm II: Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.

In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity. Patients with complete or partial response after the initial 3 courses optionally continue the same therapy for 3 additional courses. Patients with disease progression after 6 courses of treatment on the original arm may cross over and receive treatment on the other arm. Patients with progressive disease or stable disease after the initial 3 courses cross over to the other arm and receive treatment on that arm for 3 additional courses. Patients with responsive or stable disease after the sixth course may continue therapy on that arm.

Cohorts of 6-12 patients in each arm receive doses of suramin calculated from a clinical formula validated in prior clinical trials. Adjustments on the suramin dose are performed if the initial dose is off target and less than 50 µM peak concentration. The optimal 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 experiences dose-limiting toxicity. In the event of dose-limiting toxicity, doses of docetaxel and gemcitabine are adjusted until the optimal dose in combination with suramin is determined.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: A total of 12-24 patients (6-12 per treatment arm) will be accrued for this study within 6 months.

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 non-small cell lung cancer
- Stage IIIB* or IV NOTE: *Must not be amenable to concurrent radiotherapy and chemotherapy (e.g., presence of pleural effusion or low pulmonary reserve)
Progressive disease after prior platinum-containing regimen (e.g., cisplatin, carboplatin, or oxaliplatin)
No known brain or leptomeningeal disease, unless all of the following are true:
- Lesions were previously irradiated
- No concurrent corticosteroids
- No clinical symptoms

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

Hepatic

Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN

Renal

Creatinine no greater than 2.0 mg/dL

Cardiovascular

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

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active serious infectious process
No grade 2 or greater neuropathy
No uncontrolled diabetes mellitus
No psychiatric disorder that would preclude giving informed consent or interfere with study follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
At least 28 days since prior cytotoxic chemotherapy and recovered
No more than 2 prior chemotherapy regimens
No prior docetaxel
No prior gemcitabine

Endocrine therapy

See Disease Characteristics

Radiotherapy

See Disease Characteristics
Prior radiotherapy allowed

Surgery

Not specified

Other

At least 2 weeks since prior epidermal growth factor receptor therapy
Prior suramin allowed
No concurrent anti-HIV medications for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066768

Locations

United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at 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

Principal Investigator:

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

No publications provided

Study ID Numbers:	CDR0000318808, OSU-0238, NCI-5889
Study First Received:	August 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00066768 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
Antimetabolites
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Docetaxel
Antiparasitic Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms

Therapeutic Uses
Gemcitabine
Antinematodal Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Suramin
Enzyme Inhibitors
Anthelmintics
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases

ClinicalTrials.gov processed this record on November 27, 2009