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Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Gemcitabine/Paraplatin® (Carboplatin) Followed by Taxol® (Paclitaxel) in Patients With Performance Status = 2,3 or Other Significant Co-Morbidity (HIV Infection or s/p Organ Transplantation) in Advanced Non-Small Cell Lung Cancer



- Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin
followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in
regard to response rate, median survival, and one year survival.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is multicenter study.

- Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2
courses. In week 7, all patients proceed to part 2 regardless of disease response.

- Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks.
Treatment repeats every 8 weeks in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed non-small lung cancer (NSCLC) of any of the following
histologic types:

- Squamous cell

- Adenocarcinoma

- Large cell carcinoma

- Unspecified

- Evidence of at least 1 of the following criteria:

- Newly diagnosed inoperable stage IIIB (pleural effusion) disease

- Patients with stage III disease who are unable to undergo combined modality

- Stage IV disease

- Recurrent non-small cell lung cancer regardless of site

- Diagnosis based on sputum cytology acceptable if confirmed by an independent
pathologic review

- Patients must have measurable or evaluable disease

- Measurable or evaluable disease must be outside the previous radiation field or
a new lesion must be present

- Patients with brain metastases are eligible, provided they are either asymptomatic
(no neurological symptoms or signs, no evidence of midline shift), or controlled
(i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid
therapy for at least two weeks with no evidence of progression by symptoms or
radiologic imaging


- ECOG performance status of 2 or 3 OR HIV-positive OR underwent prior status post
organ transplantation

- No active serious infection (except for HIV infection)

- No symptomatic, untreated malignant pericardial effusion

- No congestive heart failure

- No other serious underlying medical condition that would otherwise impair their
ability to receive protocol treatment

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm ^3

- Creatinine clearance ≥ 40 mL/min

- Creatinine ≤ 1.8 mg/dL

- Bilirubin < 1.5 mg/dL

- SGOT ≤ 2 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Males or females of reproductive potential may not participate unless they have
agreed to use effective barrier contraceptive methods

- No prior malignancy within the past 5 years except for adequately treated basal cell
or squamous cell skin cancer or carcinoma in situ of the cervix


- See Disease Characteristics

- Prior chemotherapy is not allowed

- At least three weeks since prior radiotherapy and recovered from all toxicities

- At least three weeks must have elapsed from major surgery and recovered from all
adverse effects of surgery

- No prior colony-stimulating factors or interferon

- No concurrent hormonal, biologic, or radiotherapy to measurable lesions

- Patients may receive concurrent palliative radiotherapy to small-field
nonmeasurable sites of disease (e.g., painful bony metastases)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Julie Brahmer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

JHOC-J0428, CDR0000450843



Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201