Overview

Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer. 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Lenograstim
Criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically proven advanced malignancy that is refractory to prior
therapy or unlikely to benefit from standard therapy (e.g., chemotherapy,
radiotherapy, and surgery)

- Part I: Previously untreated OR minimally pretreated

- Ineligible for part I and considered heavily pretreated if:

- Prior radiotherapy to wide ports involving the pelvis or at least 25%
of bone marrow

- Greater than 6 courses of prior combination chemotherapy including
alkylating agent

- Prior nitrosoureas or mitomycin

- Widespread bone metastases with bone marrow involvement by bone marrow
biopsy (positive bilateral bone marrow biopsy for lymphoma patients)

- Part II: Heavily pretreated as defined above

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Hemoglobin greater than 9 mg/dL

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

Renal:

- Creatinine less than 1.5 mg/dL

Cardiovascular:

- No uncontrolled hypertension

- No angina pectoris

- No clinically significant, multifocal, uncontrolled cardiac dysrhythmias

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active serious infection

- No clinically severe peripheral neuropathy (grade 1 or worse)

- No nonmalignant medical condition that would preclude compliance or increase risk of
participation in study

- No hypersensitivity to E. coli derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No other concurrent colony stimulating factors for prophylactic purposes

Chemotherapy:

- At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and
mitomycin) and recovered

Endocrine therapy:

- No chronic oral corticosteroids

- No concurrent corticosteroids except as prophylactic antiemetic

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

Other:

- At least 1 month since prior investigational agent

- No prophylactic oral or IV antibiotics for neutropenia unless fever present

- No other concurrent anticancer treatment or investigational agent