A Phase 2 interventional study of cisplatin and gemcitabine hydrochloride in Lung Cancer, sponsored by SWOG Cancer Research Network. Completed at 147 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are assigned to 1 of 2 treatment arms based on RRM1 and ERCC1 gene expression.
Tumor samples acquired at the time of surgery are analyzed by immunofluorescence-based automated quantitative analysis for in situ expression of RRM1 and ERCC1. If available, additional samples are assessed using RT-PCR and real-time quantitative PCR for RRM1 and ERCC1 expression levels; polymorphism analysis for RRM1 and ERCC1 expression at the protein level; and tissue microarray analysis of genes associated with DNA synthesis, damage repair, and drug efficacy.
After completion of study therapy, patients are followed every 6 months for up to 2 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 85 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
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:
Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
PATIENT CHARACTERISTICS:
No other prior malignancy except for the following:
PRIOR CONCURRENT THERAPY:
No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: cisplatin · Drug: gemcitabine hydrochloride
Given IV
Given IV
Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting
Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.
Time frame: From time of registration to 84 days after surgical resection.
Two-year Disease-free Survival
Time frame: From time of registration to maximum of 2 years
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0
Patients in the active monitoring arm were not followed for adverse events.
Time frame: From time of registration to maximum of 2 years
Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.
RRM1 and ERCC1 protein levels are expressed as a simple score with no units.
Time frame: From time of registration to maximum of 2 years
Analytical Performance of the Biomarker Assay
Time frame: From time of registration to maximum of 2 years
Generation of Results on in Situ Protein Expression and Other Assays for Genes Involved in Drug Efficacy
Time frame: From time of registration to maximum of 2 years
Relationship Between RNA and Protein Expression of RRM1 and ERCC1
Time frame: From time of registration to maximum of 2 years
| Milestone | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin |
|---|---|---|
| Started | 19 | 66 |
| Eligible | 18 | 63 |
| Eligible and analyzable | 17 | 44 |
| Completed | 0 | 22 |
| Not completed | 19 | 44 |
| Withdrew: Adverse event | 0 | 22 |
| Withdrew: Ineligible | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 19 |
| Withdrew: Not protocol specified | 17 | 0 |
Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.
| Participants | All Eligible Patients |
|---|---|
| Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting | 71 |
| percentage of participants | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin |
|---|---|---|
| Two-year Disease-free Survival | 71 (43 to 87) | 83 (68 to 91) |
Patients in the active monitoring arm were not followed for adverse events.
| participants | Gemcitabine Hydrochloride and Cisplatin |
|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | 1 |
| Anorexia | 2 |
| Dehydration | 1 |
| Fatigue (asthenia, lethargy, malaise) | 2 |
| Febrile neutropenia | 2 |
| Hearing: pts w/o audiogram not enroll monitor prgm | 1 |
| Hemoglobin | 2 |
| Mucositis/stomatitis (clinical exam) - Oral cavity | 1 |
| Nausea | 4 |
| Neutrophils/granulocytes (ANC/AGC) | 17 |
| Platelets | 8 |
| Pleural effusion (non-malignant) | 1 |
| Potassium, serum-low (hypokalemia) | 1 |
| Renal failure | 1 |
| SVT and nodal arrhythmia - Sinus bradycardia | 1 |
| Sodium, serum-low (hyponatremia) | 2 |
| Syncope (fainting) | 1 |
| Thrombosis/embolism (vascular access-related) | 1 |
| Thrombosis/thrombus/embolism | 1 |
| Vomiting | 4 |
RRM1 and ERCC1 protein levels are expressed as a simple score with no units.
| Scores | All Patients |
|---|---|
| RRM1 Protein Score | 39.7 (2.4 to 234.3) |
| ERCC1 Protein Score | 41.9 (4.3 to 211.2) |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
| Scores | All Patients |
|---|---|
| RRM1 Protein Score | 39.7 (2.4 to 234.3) |
| ERCC1 Protein Score | 41.9 (4.3 to 211.2) |
Collected over From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine Hydrochloride and Cisplatin | — | 2/43 (4.7%) | 41/43 (95.3%) |
| Event | Gemcitabine Hydrochloride and Cisplatin |
|---|---|
| Thrombosis/embolism (vascular access-related)Injury, poisoning and procedural complications | 1/43 |
| Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders | 1/43 |
| Event | Gemcitabine Hydrochloride and Cisplatin |
|---|---|
| NauseaGastrointestinal disorders | 34/43 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 31/43 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 28/43 |
| HemoglobinBlood and lymphatic system disorders | 25/43 |
| VomitingGastrointestinal disorders | 18/43 |
| AnorexiaMetabolism and nutrition disorders | 18/43 |
| ConstipationGastrointestinal disorders | 16/43 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 15/43 |
| PlateletsInvestigations | 14/43 |
| DizzinessNervous system disorders | 13/43 |
| Age, Continuous(years) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| Median | 68.8 (41.6 to 81.7) | 63.3 (41.6 to 84.2) | 64 (41.6 to 84.2) |
| Sex: Female, Male(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| Female | 7 | 37 | 44 |
| Male | 11 | 26 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 16 | 58 | 74 |
| Unknown or Not Reported | 2 | 5 | 7 |
| Race (NIH/OMB)(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 0 | 8 | 8 |
| White | 14 | 52 | 66 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Histology(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| Adenocarcinoma | 8 | 44 | 52 |
| Squamous | 8 | 17 | 25 |
| Large Cell | 0 | 1 | 1 |
| Bronchioloalveolar | 1 | 0 | 1 |
| Other | 1 | 1 | 2 |
| Performance Status(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| 0 | 13 | 31 | 44 |
| 1 | 5 | 32 | 37 |
| Smoking History(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| Current | 7 | 26 | 33 |
| Former | 9 | 30 | 39 |
| Never | 2 | 7 | 9 |
| Stage(Participants) | Active Monitoring | Gemcitabine Hydrochloride and Cisplatin | Total |
|---|---|---|---|
| IA | 3 | 22 | 25 |
| IB | 15 | 41 | 56 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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