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Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: September 16, 2013
Last verified: October 2001

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 sulfate Drug: vindesine Drug: vinorelbine tartrate Procedure: drug resistance inhibition treatment Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00002887

Canada, Ontario
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
Ottawa Regional Cancer Centre
Study Chair: David J. Stewart, MD, FRCPC Ottawa Regional Cancer Centre
  More Information Identifier: NCT00002887     History of Changes
Other Study ID Numbers: CDR0000065207
Study First Received: November 1, 1999
Last Updated: September 16, 2013

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antisickling Agents
Nucleic Acid Synthesis Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on September 21, 2017