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Hydroxyurea Plus Combination Chemotherapy in Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Ottawa Hospital Regional Cancer Centre - General Campus
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002887
  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 is a way to kill more tumor cells.

PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: hydroxyurea
Drug: vinblastine
Drug: vindesine
Drug: vinorelbine ditartrate
Procedure: drug resistance inhibition treatment
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Etoposide Cisplatin Vinorelbine Vinorelbine tartrate Hydroxyurea Etoposide phosphate Vinblastine Vinblastine sulfate Vindesine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER

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

Estimated Enrollment: 30
Study Start Date: July 1995
Detailed Description:

OBJECTIVES: I. Estimate the maximum tolerated dose of hydroxyurea that can be given in combination with other chemotherapy regimens in patients with incurable non-small cell lung cancer. II. Determine the toxicity of this combination chemotherapy regimen in these patients. III. Observe the efficacy of hydroxyurea in patients with incurable non-small cell lung cancer refractory to front-line chemotherapy.

OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of hydroxyurea in combination with other chemotherapy. Groups of 3 patients take escalated doses of oral hydroxyurea three times weekly or daily throughout treatment with cisplatin plus (per their previous regimen) vinblastine, vindesine, vinorelbine, or etoposide. Treatment continues in responding and stable patients until 3 months beyond documentation of complete remission (minimum 4 courses), maximum of 6 courses beyond documentation of partial remission, or 3 courses beyond documentation of stable disease. Patients are followed every 3 weeks for 3 months, every 6 weeks for 3 months, then every 3 months until disease progression.

PROJECTED ACCRUAL: An anticipated 15-30 patients will be entered.

  Eligibility

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

DISEASE CHARACTERISTICS: Histopathologically proven non-small cell lung cancer that is incurable by surgery or radiotherapy Brain metastases allowed Demonstrated resistance to prior chemotherapy required by 1 of the following: Tumor growth or recurrence while on treatment Failure of tumor to shrink over 3 consecutive courses of treatment Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL (26 micromoles/L) AST/ALT less than 1.5 times normal Renal: Creatinine less than 1.6 mg/dL (150 micromoles/L) Cardiovascular: No uncontrolled hypertension or other cardiac disease No myocardial infarction within 6 months Other: No uncontrolled diabetes No active abuse of ethanol No allergies to study medication No active infection or other serious medical condition that precludes protocol treatment No dementia or significantly altered mental status that precludes informed consent No prior melanoma or malignancy of the following sites: Breast Kidney Thyroid Salivary glands Endometrium No other second malignancy within 5 years except: Nonmelanomatous skin cancer Carcinoma in situ of cervix No pregnant or nursing women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Recovery from any treatment-limiting toxicity required Biologic therapy: Not specified Chemotherapy: At least 3 weeks since myelosuppressive chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiotherapy unless to a limb or limited treatment area Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002887

Locations
Canada, Ontario
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
Ottawa Hospital Regional Cancer Centre - General Campus
Investigators
Study Chair: David J. Stewart, MD, FRCPC Ottawa Hospital Regional Cancer Centre - General Campus
  More Information

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

Study ID Numbers: CDR0000065207, CAN-OTT-9501, NCI-V96-1099
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002887  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Hydroxyurea
Vindesine
Vinblastine
Etoposide phosphate
Recurrence
Carcinoma
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Hematologic Agents
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009