Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2008-10-01
• 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 I trial to study the effectiveness of combining irinotecan and gemcitabine in treating patients who have unresectable or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Gemcitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:

• Bladder cancer - no more than 1 prior therapy

• Breast cancer - no more than 2 prior therapies

• Colorectal cancer - no more than 1 prior therapy

• Kidney cancer - no prior therapy

• Lung cancer - no more than 1 prior therapy

• Pancreatic cancer - no prior therapy

• Bidimensionally measurable disease outside a previously irradiated field

• At least 2 cm x 2 cm

• No known bone metastases

• CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

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

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

Hepatic:

• Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor

• SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

• No known Gilbert's disease

Renal:

• Creatinine no greater than 1.8 mg/dL

• Calcium less than 12.0 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months

• No congestive heart failure requiring therapy

Other:

• No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection

• No psychiatric disorders that would prevent compliance

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

• No history of seizures

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent sargramostim (GM-CSF)

• No concurrent immunotherapy

Chemotherapy:

• No prior irinotecan, topotecan, or gemcitabine

• Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy to less than 30% of bone marrow

• No prior whole pelvic radiotherapy

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis