Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
Brief summary
RATIONALE: Anticoagulants, such as lepirudin, may help prevent blood clots from forming in patients who have received chemotherapy for small cell lung cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy. OUTLINE: This is a dose escalation (in individual patients) study. Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached. The patient then continues treatment on the maximum tolerated dose. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18-24 months.
Interventions
BIOLOGICALlepirudin
lepirudin
Sponsors
National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: 1. Pathologically confirmed recurrent or extensive stage small cell lung cancer. 2. Received at least one prior chemotherapy regimen 3. Measurable or evaluable disease that has not been irradiated 4. No pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion 5. Brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases PATIENT CHARACTERISTICS: 1. Age: Not specified 2. Performance status: Karnofsky 60-100% 3. Life expectancy: Not specified 4. Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 5. Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal 6. Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min 7. Cardiovascular: No unstable heart rhythm No unstable angina No clinical evidence of congestive heart failure No prior cerebrovascular accident or stroke No uncontrolled or severe hypertension 8. Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 9. At least 6 weeks since any signs or symptoms of bleeding No history of bleeding disorder 10. No bacterial endocarditis or other active infection PRIOR CONCURRENT THERAPY: 1. Biologic therapy: Not specified 2. Chemotherapy: At least 3 weeks since prior chemotherapy 3. Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy 4. Surgery: At least 6 weeks since major surgery, trauma, or needle biopsy of any organ 5. Other: No concurrent anticoagulant or platelet inhibitor therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer | 18 months | Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments. |
Countries
United States
Participant flow
Recruitment details
One participant was enrolled to the trial and started on 10mg and increased to 20mg. However developed progression of disease and was removed from the trial.
Pre-assignment details
Funding was pulled and therefore the trial was not completed.
Participants by arm
| Arm | Count |
|---|---|
| Lepirudin Dose level 1: 10 mg once daily -\> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -\> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -\> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -\> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -\> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -\> (total dose, 50 mg/d) | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Lepirudin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer
Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.
Time frame: 18 months
Population: No data were collected