Trials / Unknown
UnknownNCT00002887
Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Ottawa Regional Cancer Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cisplatin | |
| DRUG | etoposide | |
| DRUG | hydroxyurea | |
| DRUG | vinblastine sulfate | |
| DRUG | vindesine | |
| DRUG | vinorelbine tartrate | |
| PROCEDURE | drug resistance inhibition treatment |
Timeline
- Start date
- 1995-07-01
- First posted
- 2004-03-26
- Last updated
- 2013-09-17
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00002887. Inclusion in this directory is not an endorsement.