Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00086983
  Purpose

RATIONALE: Drugs used in chemotherapy, such as rebeccamycin analog and oxaliplatin, work in 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: This phase I trial is studying the side effects and best dose of rebeccamycin analog and oxaliplatin in treating patients with refractory solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: becatecarin
Drug: oxaliplatin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Oxaliplatin BMS 181176
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of XL119 (Rebeccamycin Analogue) In Combination With Oxaliplatin In Patients With Refractory Solid Tumors

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

Primary Outcome Measures:
  • Maximum tolerated dose at end of phase I [ Designated as safety issue: Yes ]
  • Dose limiting toxicity as measured by Common Toxicity Criteria after course 1 [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: May 2004
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of rebeccamycin analogue given in combination with oxaliplatin in patients with refractory solid tumors.
  • Determine the dose-limiting toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2 hours on day 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients are followed annually for survival.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

    • Refractory disease
  • Not amenable to conventional surgery, chemotherapy, or radiotherapy
  • No known brain metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • AST < 2.5 times upper limit of normal
  • Bilirubin < 1.5 mg/dL

Renal

  • Creatinine < 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior large-field radiotherapy and recovered

Surgery

  • Not specified

Other

  • At least 4 weeks since prior investigational agents
  • At least 3 weeks since prior anticancer therapy and recovered
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents or therapies
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086983

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000371910, CASE-CWRU-4Y03, CWRU-020420, NCI-5921, CASE-4Y03
Study First Received: July 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00086983  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Oxaliplatin

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009