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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Gemcitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction

• Squamous cell carcinoma OR

• Adenocarcinoma

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 100

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

• No uncontrolled hypertension

• No unstable angina

• No symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• No serious uncontrolled cardiac arrhythmia

Gastrointestinal:

• No active inflammatory bowel disease

• No significant bowel obstruction

• No chronic diarrhea

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No active infection requiring systemic therapy

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 28 days since prior biologic therapy

• No prior biologic therapy for metastatic or recurrent disease

• No concurrent sargramostim (GM-CSF)

• No concurrent immunotherapy for tumor

Chemotherapy:

• At least 28 days since prior chemotherapy

• No prior chemotherapy for metastatic or recurrent disease

• No prior gemcitabine or irinotecan

• Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed

• No other concurrent chemotherapy for tumor

Endocrine therapy:

• See Disease Characteristics

• At least 28 days since prior endocrine therapy

• No prior endocrine therapy for metastatic or recurrent disease

• No concurrent hormonal therapy for tumor

Radiotherapy:

• At least 28 days since prior radiotherapy

• No prior radiotherapy for metastatic or recurrent disease

• Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed

• No concurrent radiotherapy for tumor

Surgery:

• Prior thoraco-abdominal surgery allowed

• At least 3 weeks since prior surgery and recovered

Other:

• No other concurrent anti-cancer therapy for tumor