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Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Ralph G. Zinner, MD
  • Eric Vallieres, MD, FRCSC
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • cisplatin
  • gemcitabine hydrochloride
Other
  • active surveillance
Physician Researcher

Investigator Name:

  • Ralph G. Zinner, MD
  • Eric Vallieres, MD, FRCSC

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00792701
Volunteers:  Not Accepting Healthy Volunteers

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