NCT00003726

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 lung-cancer

Timeline
Completed

Started Nov 1998

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

June 1, 2016

Enrollment Period

2.7 years

First QC Date

November 1, 1999

Results QC Date

May 16, 2013

Last Update Submit

June 27, 2016

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Study Arms (1)

Lepirudin

EXPERIMENTAL

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)

Biological: lepirudin

Interventions

lepirudinBIOLOGICAL

lepirudin

Lepirudin

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

lepirudin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Limitations and Caveats

The funding of the trial was discontinued and therefore only one participant was enrolled to the trial and experienced no adverse events.

Results Point of Contact

Title
James Rigas, MD
Organization
Dartmouth-Hitchcock Medical Center
james.r.rigas@hitchcock.org
603-650-6344

Study Officials

  • James R. Rigas, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 3, 2004

Study Start

November 1, 1998

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

August 8, 2016

Results First Posted

August 8, 2016

Record last verified: 2016-06

Locations

US(1)