Lung Cancer Clinical Trial

Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed recurrent or extensive stage small cell lung cancer.
Received at least one prior chemotherapy regimen
Measurable or evaluable disease that has not been irradiated
No pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion
Brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

Age: Not specified
Performance status: Karnofsky 60-100%
Life expectancy: Not specified
Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
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
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
At least 6 weeks since any signs or symptoms of bleeding No history of bleeding disorder
No bacterial endocarditis or other active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy: Not specified
Chemotherapy: At least 3 weeks since prior chemotherapy
Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy
Surgery: At least 6 weeks since major surgery, trauma, or needle biopsy of any organ
Other: No concurrent anticoagulant or platelet inhibitor therapy

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00003726

Recruitment Status:

Terminated

Sponsor:

Dartmouth-Hitchcock Medical Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00003726

Recruitment Status:

Terminated

Sponsor:


Dartmouth-Hitchcock Medical Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider