Phase 2 N=85 Treatment

S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00792701 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Jul 2017

Primary outcome: Primary: Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting — 71 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cisplatin (Drug); gemcitabine hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting	71	—
SECONDARY Two-year Disease-free Survival	71; 83	—
SECONDARY Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0	1; 2; 1; 2; 2; 1	—
SECONDARY Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.	39.7; 41.9	0.003 sig

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer
Stage IA (longest tumor diameter 2-3 cm) or stage IB disease
Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery
A whole body PET scan or a combined PET/CT must be performed within 84 days
Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must have been cleared by further evaluation, including, but not limited to, any of the following:
Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear medicine imaging
Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
Completely excised primary lesion with negative gross and microscopic margins
At least two mediastinal lymph node stations sampled
Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 mg/dL
Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 1.5 times ULN
Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
No other prior malignancy except for the following:
Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
Adequately treated stage I-II cancer from which the patient is currently in complete remission
Any other cancer from which the patient has been disease-free for 5 years
Willing to provide prior smoking history

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior systemic chemotherapy or biologic therapy for lung cancer
No prior thoracic radiation therapy (RT) (including RT to the chest wall)
No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00792701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.