Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: cisplatin (Drug); etoposide (Drug); hydroxyurea (Drug); vinblastine sulfate (Drug); vindesine (Drug); vinorelbine tartrate (Drug); drug resistance inhibition treatment (Procedure)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Ottawa Regional Cancer Centre Official(s) and/or principal investigator(s): David J. Stewart, MD, FRCPC, Study Chair, Affiliation: Ottawa Regional Cancer Centre
Summary
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.
Clinical Details
Official title: PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER
Study design: Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ottawa Regional Cancer Centre - General Campus, Ottawa, Ontario K1H 1C4, Canada
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1995
Last updated: September 16, 2013
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