Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

NCT00083161 | Completed Phase 2

• 2 other identifiers: CDR0000363799GLO-03-06-06
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Safety

  From time of registration to 30 days post treatment of last cycle.

• Effect of metronomic chemotherapy on circulating endothelial cells

  Collected cycle 1/day 1 of chemotherapy, Cycle 1/day 8, cycle 1/day 22, and then day 85 and 141, and at disease progression.

  Baseline to progression

Secondary Outcomes (3)

• Progression-free survival

  Registration to time of progression

• Response rate

  From Registration to time of disease progression

• Overall survival

  From registration to time patient expires

Study Arms (1)

Oral cyclophosphamide plus standard cisplatin with etoposide

EXPERIMENTAL

1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3 2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles 3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle

Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide

Interventions

cisplatin DRUG

60 mg/m2 IV day 1, every 21 days for 4 cycles.

Oral cyclophosphamide plus standard cisplatin with etoposide

cyclophosphamide DRUG

25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression

Also known as: Cytoxan

Oral cyclophosphamide plus standard cisplatin with etoposide

etoposide DRUG

120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3

Also known as: VP-16

Oral cyclophosphamide plus standard cisplatin with etoposide

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field) * Measurable disease * Concurrent CNS metastases allowed provided patient remains asymptomatic * Radiotherapy or surgery for uncontrolled symptoms allowed before study entry PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * ALT ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 2 times ULN Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * Concurrent corticosteroids for brain metastases allowed Radiotherapy * See Disease Characteristics * Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated * No concurrent radiotherapy Surgery * See Disease Characteristics

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

Sponsors & Collaborators

• Gundersen Lutheran Health System: lead

Study Sites (1)

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Cisplatin; Cyclophosphamide; Etoposide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ronald S. Go, MD

  Gundersen Lutheran Center for Cancer and Blood

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: June 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

US (1)