Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00276588
• Date of registration: 12/01/2006
• Primary sponsor: Sidney Kimmel Comprehensive Cancer Center
• Public title: Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
• Scientific title: 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
• Date of first enrolment: July 2005
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00276588
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Julie Brahmer, MD
• Affiliation: Sidney Kimmel Comprehensive Cancer Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- 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
therapy

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: carboplatin

Drug: gemcitabine hydrochloride

Drug: paclitaxel

Primary Outcome(s)

Overall survival [Time Frame: No]

Progression-free survival [Time Frame: No]

Time to progression [Time Frame: No]

Time to treatment failure [Time Frame: No]

Secondary Outcome(s)

Duration of response (complete response and partial response) [Time Frame: No]

Secondary ID(s)

BMS-JHOC-J0428

JHOC-04112308

JHOC-BRAAN-21048

JHOC-J0428

JHOC-J0428, CDR0000450843

MSGCC-0060

P30CA006973

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)