S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• carboplatin — DRUG
  AUC=5.5 day 1 every 21 days X 3
• cisplatin — DRUG
  IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3
• docetaxel — DRUG
  IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3
• gemcitabine — DRUG
  IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3
• paclitaxel — DRUG
  IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3
• vinorelbine — DRUG
  IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer

Key Dates

Start date

Oct 31, 1998

Status verified

Oct 2012

Primary completion

Jan 31, 2001

Completion

Jan 31, 2007

Study Design

Enrollment

204 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: carboplatin/gemcitabine/paclitaxel
  IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3
• Experimental: cisplatin/vinorelbine/docetaxel
  IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3

Locations (84)

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