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PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Stewart, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Ottawa Regional Cancer Centre

Authority:

United States: Federal Government

Study ID:

CDR0000065207

NCT ID:

NCT00002887

Start Date:

July 1995

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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