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Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer

Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00301808
Enrollment
29
Registered
2006-03-13
Start date
2005-11-30
Completion date
2012-10-31
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Brief summary

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

Detailed description

OBJECTIVES: Primary * Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel. Secondary * Assess the progression-free survival and overall survival. * Assess the toxicity of this regimen. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses. After completion of study therapy, patients are followed at 1 month and periodically thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Interventions

DRUGCisplatin

Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43

DRUGDocetaxel

Docetaxel 75 mg/m2 on day 1 of each cycle

DRUGPemetrexed disodium

Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43

RADIATIONRadiation therapy

Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria: * Stage IIIA disease, meeting all of the following criteria: * Mediastinal lymph node involvement * Greater than one mediastinal lymph node enlarged on CT scan, confirmed by positron emission tomography (PET) scan * Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan * Stage IIIB disease, meeting all of the following criteria: * N3 lymph node involvement * Enlarged N3 lymph nodes on CT scan confirmed by PET scan * Lymph node involvement may not extend to cervical lymph nodes other than supraclavicular lymph nodes * Right-sided primary tumor with left vocal cord paralysis * Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan * No evidence of malignant pleural effusion unless effusion is only evident on CT scan * No more than 1 parenchymal lesions on the same or opposite sides of the lung * No brain metastases by CT scan or MRI PATIENT CHARACTERISTICS: * SWOG performance status 0 or 1 * Platelet count ≥ 100,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Creatinine clearance ≥ 45 mL/min * Bilirubin normal * Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40% * FEV\_1 ≥ 70% of predicted * DLCO ≥ 50 mL/min * No other concurrent malignancy * Prior malignancy allowed provided it is in clinical control and is not likely to impact clinical outcome in the opinion of the treating physician * No peripheral neuropathy ≥ grade 2 * No serious medical illness, including, but not limited to, any of the following: * Uncontrolled congestive heart failure * Uncontrolled angina * Myocardial infarction * Cerebrovascular event within the past 6 months * History of chronic active hepatitis * History of HIV infection * Active bacterial infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for NSCLC * No concurrent participation in another therapeutic investigational study * Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function * No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration * Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or celecoxib) must be willing or able to discontinue usage 5 days prior to, during, and for 2 days after pemetrexed disodium administration

Design outcomes

Primary

MeasureTime frameDescription
Probability of Overall Survival at One Yearat 1 yearOverall Survival at one year using Kaplan-Meier product-limit analysis

Secondary

MeasureTime frameDescription
Progression-free SurvivalApproximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.Progression-free survival using Kaplan-Meier estimates
Overall SurvivalDate of registration to the date of deathOverall survival using Kaplan-Meier estimates
Safety Outcomes72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a yearToxicity: total number of SAEs and other AEs

Countries

United States

Participant flow

Participants by arm

ArmCount
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
29
Total29

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event5
Overall StudyDeath3
Overall StudyLack of Efficacy4

Baseline characteristics

CharacteristicCisplatin, Docetaxel & Radiation Therapy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
22 Participants
Age, Continuous60.76 years
STANDARD_DEVIATION 8.03
Region of Enrollment
United States
29 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
29 / 29
serious
Total, serious adverse events
15 / 29

Outcome results

Primary

Probability of Overall Survival at One Year

Overall Survival at one year using Kaplan-Meier product-limit analysis

Time frame: at 1 year

ArmMeasureValue (NUMBER)
Cisplatin, Docetaxel & Radiation TherapyProbability of Overall Survival at One Year0.66 probability of overall survival at 1 yr.
95% CI: [0.48, 0.84]
Secondary

Overall Survival

Overall survival using Kaplan-Meier estimates

Time frame: Date of registration to the date of death

ArmMeasureValue (MEDIAN)
Cisplatin, Docetaxel & Radiation TherapyOverall Survival33.7 months
Secondary

Progression-free Survival

Progression-free survival using Kaplan-Meier estimates

Time frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.

ArmMeasureValue (MEDIAN)
Cisplatin, Docetaxel & Radiation TherapyProgression-free Survival16.9 months
Secondary

Safety Outcomes

Toxicity: total number of SAEs and other AEs

Time frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year

ArmMeasureGroupValue (NUMBER)
Cisplatin, Docetaxel & Radiation TherapySafety Outcomesother (grade 0, 1, or 2)245 Adverse event
Cisplatin, Docetaxel & Radiation TherapySafety OutcomesSerious (grade 3 or 4)20 Adverse event

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026