A Phase 2 interventional study of cisplatin and gemcitabine hydrochloride in Lung Cancer, sponsored by City of Hope Medical Center. Terminated. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by City of Hope Medical Center · 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 more than one drug (combination chemotherapy) together with radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin, and radiation therapy works in treating patients with stage II or stage III non-small cell lung cancer.
OBJECTIVES:
OUTLINE: Patients undergo surgical resection of their tumor and mediastinal lymph node dissection. Patients with complete surgical eradication of their disease or pathologic evidence of microscopic residual disease proceed to adjuvant chemotherapy.
Within approximately 60 days after surgical resection, patients receive adjuvant chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Beginning 130-144 days after surgery, patients undergo radiotherapy once daily, five days a week, for approximately 6 weeks.
Tumor tissue specimens are obtained at the time of surgical resection for pharmacodynamic and biomarker correlative studies. Specimens are examined by reverse transcriptase-polymerase chain reaction to measure mRNA expression of target oncogenes (i.e., DNA repair gene ERCC-1 and M2 subunit of the DNA repair gene ribonucleotide reductase) and enzymes (i.e., cytidine/deoxycytidine deaminase and kinase). Resected specimens are also assessed by IHC for the expression of BCL2, P53, and HER2-neu genes.
After completion of study therapy, patients are followed every 6 months for 5 years and annually thereafter.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes:
Meeting the following staging criteria:
No evidence of metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
Drug: cisplatin · Drug: gemcitabine hydrochloride · Genetic: gene expression analysis · Genetic: reverse transcriptase-polymerase chain reaction · Other: immunohistochemistry staining method · Procedure: adjuvant therapy · Procedure: conventional surgery · Radiation: radiation therapy
Two-year Progression-free Survival From the Date of Surgery
Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).
Time frame: 2 years post-surgery
| Milestone | Gemcitabine + Cisplatin |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).
| percentage of participants | Gemcitabine + Cisplatin |
|---|---|
| Two-year Progression-free Survival From the Date of Surgery | 67.6 (9.0 to NA) |
Collected over Adverse events were recorded over a period of 46 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine + Cisplatin | — | 0/3 (0%) | 3/3 (100%) |
| Event | Gemcitabine + Cisplatin |
|---|---|
| Hemoglobin decreasedBlood and lymphatic system disorders | 3/3 |
| FatigueGeneral disorders | 3/3 |
| PainGeneral disorders | 3/3 |
| DehydrationMetabolism and nutrition disorders | 3/3 |
| HypoalbuminemiaMetabolism and nutrition disorders | 3/3 |
| HypocalcemiaMetabolism and nutrition disorders | 3/3 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/3 |
| Respiratory disorderRespiratory, thoracic and mediastinal disorders | 3/3 |
| Sinus tachycardiaCardiac disorders | 2/3 |
| Gastrointestinal disorderGastrointestinal disorders | 2/3 |
| Age, Continuous(years) | Gemcitabine + Cisplatin |
|---|---|
| Median | 66 (63 to 71) |
| Sex: Female, Male(Participants) | Gemcitabine + Cisplatin |
|---|---|
| Female | 0 |
| Male | 3 |
| Region of Enrollment(participants) | Gemcitabine + Cisplatin |
|---|---|
| United States | 3 |
No study locations are listed for this record.
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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