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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
cisplatin
etoposide
hydroxyurea
vinblastine sulfate
vindesine
vinorelbine tartrate
drug resistance inhibition treatment
Sponsored by
Ottawa Regional Cancer Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Regional Cancer Centre - General Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 16, 2013
Sponsor
Ottawa Regional Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00002887
Brief Title
Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
Official Title
PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
October 2001
Overall Recruitment Status
Unknown status
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Regional Cancer Centre

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
vindesine
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Intervention Type
Procedure
Intervention Name(s)
drug resistance inhibition treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Stewart, MD, FRCPC
Organizational Affiliation
Ottawa Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Ottawa Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada

12. IPD Sharing Statement

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

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