Gemcitabine and Cisplatin in Treating Patients With Metastatic or Recurrent Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004090
First received: December 10, 1999
Last updated: July 9, 2013
Last verified: January 2011
  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.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study

Resource links provided by NLM:


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

Study Start Date: August 1999
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent nonhematologic malignancy that is not amenable to or has failed standard therapy Measurable or evaluable disease No uncontrolled brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Pulmonary: No respiratory failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection or other concurrent severe medical illness that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered No prior cisplatin or gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

  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: NCT00004090

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Al B. Benson, MD, FACP Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Albert B. Benson, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00004090     History of Changes
Other Study ID Numbers: NU CINJ98X1, NU-CINJ98X1, NCI-G99-1581
Study First Received: December 10, 1999
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014