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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004189
First received: January 21, 2000
Last updated: February 8, 2013
Last verified: September 2003
  Purpose

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.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: filgrastim
Drug: becatecarin
Drug: cisplatin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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:


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

Enrollment: 40
Study Start Date: October 1999
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
See detailed description.
Biological: filgrastim Drug: becatecarin Drug: cisplatin

Detailed Description:

OBJECTIVES:

I. Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or without filgrastim (G-CSF) in patients with advanced malignancies.

II. Determine the qualitative and quantitative toxicities of these regimens in these patients.

III. Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin and if there are sequence dependent pharmacokinetic effects.

IV. 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.

  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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Lisa Hammond, MD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004189     History of Changes
Other Study ID Numbers: CDR0000067430, UTHSC-IDD-98-34, SACI-IDD-98-34, NCI-T98-0069
Study First Received: January 21, 2000
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

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:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cisplatin
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014