S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

Conditions

• Esophageal Cancer
• Gastric Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• gemcitabine hydrochloride — DRUG
  1,000mg/m2, IV over 30 min, days 1 \& 8, q 21 days
• irinotecan hydrochloride — DRUG
  100 mg/m2, IV over 90 min, days 1 \& 8, q 21days

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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.

Key Dates

Start date

Apr 30, 2001

Status verified

Jun 2012

Primary completion

Apr 30, 2006

Completion

Apr 30, 2006

Study Design

Enrollment

61 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Gemcitabine + Irinotecan
  Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days

Primary Outcome Measure

6-month survival rate [ Time Frame: 6 months after registration ]

Locations (96)

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