Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and pemetrexed disodium

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?148 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Alliance for Clinical Trials in Oncology
Interventions being studied: Drug: carboplatin; Drug: pemetrexed disodium; Radiation: radiation

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Previously untreated disease
No mixed histology
Extensive-stage disease
Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
No symptomatic, untreated, or uncontrolled CNS metastases
CNS metastases previously treated with whole-brain radiotherapy allowed PATIENT CHARACTERISTICS: Age
18 and over Performance status
ECOG 0-2 Life expectancy
At least 12 weeks Hematopoietic
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Hemoglobin ≥ 9.0 g/dL Hepatic
Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
Direct bilirubin normal
ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement) Renal
Creatinine clearance ≥ 45 mL/min Cardiovascular
No angina pectoris
No congestive heart failure within the past 3 months, unless ejection fraction \> 40%
No cardiac arrhythmia
No myocardial infarction within the past 3 months
No hypertension, including labile hypertension Pulmonary
No interstitial pneumonia
No extensive and symptomatic interstitial fibrosis of the lung Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of poor compliance with antihypertensive medication
Able to take folic acid, cyanocobalamin (vitamin B\_12) supplementation, or dexamethasone
No uncontrolled diabetes
No serious condition that would preclude study participation
No clinically significant infection
No significant traumatic injury
No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed \< 5 years prior to study entry
No seizure disorder
No other severe and/or uncontrolled medical condition PRIOR CONCURRENT THERAPY: Biologic therapy
No concurrent immunotherapy
No concurrent immunomodulating agents Chemotherapy
No other concurrent chemotherapy Endocrine therapy
No concurrent hormonal therapy Radiotherapy
See Disease Characteristics
Prior palliative radiotherapy allowed
No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome
No concurrent radiotherapy Surgery
More than 4 weeks since prior major surgery\
(i.e., laparotomy) or open biopsy
More than 2 weeks since prior minor surgery\
NOTE: \*Insertion of a vascular access device is not considered major or minor surgery Other
More than 4 weeks since prior investigational therapy
No concurrent Hypericum perforatum (St. John's wort)
No concurrent inducers or inhibitors of CYP3A4
No concurrent medications that are metabolized by CYP3A4
No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment
No other concurrent cytostatic or cytotoxic agents

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic ScottsdaleScottsdale, Arizona
Aurora Presbyterian HospitalAurora, Colorado
Boulder Community HospitalBoulder, Colorado
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
St. Anthony Central HospitalDenver, Colorado
Porter Adventist HospitalDenver, Colorado
Presbyterian - St. Luke's Medical CenterDenver, Colorado
St. Joseph HospitalDenver, Colorado
Rose Medical CenterDenver, Colorado
CCOP - Colorado Cancer Research ProgramDenver, Colorado
Swedish Medical CenterEnglewood, Colorado
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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