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)

NCT00916669 | Withdrawn Phase 2 DMC

• 1 other identifier: 08-097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Small Cell Lung Cancer

Keywords

SCLC; enoxaparin sodium; cisplatin; etoposide

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• 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.

  2 years

• To evaluate toxicity and determine the rates of bleeding complications in this patient population.

  2 years

Study Arms (3)

Group A

ACTIVE COMPARATOR

Cisplatin and Etoposide

Drug: Etoposide; Drug: Cisplatin

Group B

EXPERIMENTAL

Cisplatin and etoposide, plus low-dose enoxaparin sodium

Drug: Etoposide; Drug: Cisplatin; Drug: enoxaparin sodium

Group C

EXPERIMENTAL

Cisplatin and etoposide, plus high-dose enoxaparin sodium

Drug: Etoposide; Drug: Cisplatin; Drug: enoxaparin sodium

Interventions

Etoposide DRUG

Etoposide given as an infusion on day 1, day 2 and day 3 of a three-week cycle for a total of 6 cycles

Group A; Group B; Group C

Cisplatin DRUG

Given as an infusion on day 1 of a three-week cycle for a total of 6 cycles

Group A; Group B; Group C

enoxaparin sodium DRUG

Given as a subcutaneous injection in the abdomen daily during chemotherapy treatment and then continuing daily for 1 year. Dose will vary.

Also known as: Lovenox

Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• North Shore Medical Center: collaborator
• Sanofi: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

North Shore Medical Center

Peabody, Massachusetts, 01970, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Etoposide; Cisplatin; enoxaparin sodium; Enoxaparin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides

Study Officials

• Rachel Rosovsky, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: May 8, 2013

Record last verified: 2010-07

Locations

US (4)