Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer - Full Text View

Sponsor:	University of Texas
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004189

Purpose

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. 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.

PURPOSE: Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer.

Condition	Intervention	Phase
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific	Biological: filgrastim Drug: becatecarin Drug: cisplatin	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Hodgkin Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Cisplatin BMS 181176 Filgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or without filgrastim (G-CSF) in patients with advanced malignancies.
Determine the qualitative and quantitative toxicities of these regimens in these patients.
Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin and if there are sequence dependent pharmacokinetic effects.
Assess any antitumor effects of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study of a rebeccamycin analogue and cisplatin.

Part I (previously untreated or minimally pretreated patients): The first patient of each cohort receives cisplatin IV over 1 hour followed 2 hours later by a rebeccamycin analogue IV over 1 hour on day 1. The second patient in the same cohort receives the same drugs in the reverse order. The drug sequence for each additional patient within the same cohort is alternated with reference to the preceding patient. During each subsequent course, the study drugs are administered to each patient in the reverse order as compared to the prior course. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Dose escalation is initially performed without filgrastim (G-CSF). Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose at which less than 2 of 6 patients experience dose limiting toxicity (DLT). If 2 of the first 6 patients experience DLT, then dose escalation proceeds in combination with G-CSF treatment. Patients receive G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts have recovered for 2 days or until approximately day 15. Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin as above. The MTD is defined as above.

Part II (heavily pretreated patients): Heavily pretreated patients receive a rebeccamycin analogue and cisplatin starting at 2 dose levels preceding the MTD from part I.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for phase I of this study within 1.5 years and a minimum of 2 patients will be accrued for phase II of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

See Disease Characteristics
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:

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered

Surgery:

See Disease Characteristics

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004189

Locations

United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
St. Luke's Lutheran Hospital
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

University of Texas

National Cancer Institute (NCI)

Investigators

Study Chair:

Lisa Hammond, MD

University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067430, UTHSC-IDD-98-34, SACI-IDD-98-34, NCI-T98-0069
Study First Received:	January 21, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004189 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma

stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:

Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Ileal Neoplasms
Cisplatin
Jejunal Diseases
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Duodenal Diseases
Jejunal Neoplasms

Immunoproliferative Disorders
Neoplasms by Histologic Type
Digestive System Neoplasms
Immune System Diseases
Intestinal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on November 05, 2009