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A Randomized Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy in Patients With Stage Small Cell Lung Cancer (SCLC)

This study has been withdrawn prior to enrollment.
(sponsor withdrew funding prior to patient enrollment)
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
North Shore Medical Center
Sanofi
Information provided by (Responsible Party):
Rachel P. Rosovsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00916669
First received: June 5, 2009
Last updated: May 7, 2013
Last verified: July 2010
  Purpose

The purpose of this research study is to see if adding enoxaparin sodium to standard treatment with the chemotherapy drugs cisplatin and etoposide will help treat extensive stage SCLC. Two different doses of enoxaparin sodium will be studied in order to determine if one dose is more effective than the other. Enoxaparin sodium (Lovenox) is a drug that is approved by the FDA to help treat or prevent blood clots. Results from previous research studies suggest that adding enoxaparin sodium to standard treatment improved the response to treatment for some study participants with various types of cancer.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Etoposide
Drug: Cisplatin
Drug: enoxaparin sodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study to Evaluate the Effect of Two Different Doses of Enoxaparin Sodium in Combination With Standard Chemotherapy (Cisplatin Plus Etoposide) With Respect to Time to Tumor Progression (TTP) in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (SCLC) Without Underlying Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To evaluate the prophylactic and treatment doses of Enoxaparin sodium given in combination with standard chemotherapy compared to standard chemotherapy alone with respect to time to tumor progression in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of 2 different doses of enoxaparin sodium in combination with chemotherapy and chemotherapy alone on biomarkers of angiogenesis and to identify if these markers correlate with overall survival and progression free survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate toxicity and determine the rates of bleeding complications in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Cisplatin and Etoposide
Drug: Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Drug: Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Experimental: Group B
Cisplatin and etoposide, plus low-dose enoxaparin sodium
Drug: Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Drug: Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Drug: enoxaparin sodium
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Other Name: Lovenox
Experimental: Group C
Cisplatin and etoposide, plus high-dose enoxaparin sodium
Drug: Etoposide
Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles
Drug: Cisplatin
Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles
Drug: enoxaparin sodium
Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.
Other Name: Lovenox

Detailed Description:
  • Since no one knows which of the study options are best, participants will be randomized into one of three study treatment groups. Group A will receive cisplatin and etoposide. Group B will receive cisplatin and etoposide plus low-dose enoxaparin sodium. Group C will receive cisplatin and etoposide plus high-dose enoxaparin sodium.
  • Study treatment will be divided into chemotherapy and post-chemotherapy periods. All three groups (Group A, B and C) will receive six 3-week cycles of chemotherapy. Groups B and C will also receive daily enoxaparin sodium during the chemotherapy stage and daily enoxaparin sodium for 1 year after the chemotherapy.
  • Cisplatin and etoposide are given as an infusion in 3-week cycles for up to six cycles. Enoxaparin sodium is given as an injection under the skin into the sides of the abdomen. Participants will be instructed in how to give themselves the injections.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically or cytologically documented extensive disease small cell lung cancer. Only small cell histology is eligible. Mixed histology is not eligible. Patients who are considered to have operable disease are not eligible
  • Radiographic measurable disease by RECIST criteria
  • Life expectancy of greater than 4 months and ECOG Performance Status of less than or equal to 2
  • Patients must be an appropriate candidate for the standard combination of cisplatin and etoposide for SCLC. There are no restrictions on radiotherapy
  • No prior chemotherapy for SCLC cancer
  • Participants must meet the hematological, renal and hepatic function requirements outlined in the protocol
  • If brain or bone metastases are present at the time of initial diagnosis, patients must have completed radiation treatment at least 2 weeks before starting the study
  • No active uncontrolled infection
  • No other serious illness or medical condition that in the opinion of the investigator would be expected to interfere with the subject's ability to receive study treatment or comply with study procedures

Exclusion Criteria:

  • New (defined as 6 months or less) or symptomatic thrombosis at the time of enrollment
  • Indication for anticoagulant treatment such as mechanical heart valves, atrial fibrillation, or previous VTE
  • Contraindication or known hypersensitivity to LMWH or unfractionated heparin (UFH)
  • Active bleeding disorder
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding women
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers will are eligible if diagnosed and treated within the past 5 years; cervical in situ, and basal cell or squamous cell carcinoma of the skin
  • HIV-positive individuals on combination antiretroviral therapy are ineligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916669

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
North Shore Medical Center
Peabody, Massachusetts, United States, 01970
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
North Shore Medical Center
Sanofi
Investigators
Principal Investigator: Rachel Rosovsky, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Rachel P. Rosovsky, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00916669     History of Changes
Other Study ID Numbers: 08-097
Study First Received: June 5, 2009
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
SCLC
enoxaparin sodium
cisplatin
etoposide

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Enoxaparin
Etoposide
Etoposide phosphate
Anticoagulants
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014