Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005078
Recruitment Status : Completed
First Posted : May 16, 2003
Last Update Posted : June 8, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:

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 combining tirapazamine, carboplatin, and paclitaxel in treating patients who have advanced malignant solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: carboplatin Drug: paclitaxel Drug: tirapazamine Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of tirapazamine in combination with carboplatin and paclitaxel in patients with advanced solid tumors who have or have not received prior chemotherapy.
  • Assess the toxicity and preliminary efficacy of this regimen in these patients.
  • Determine the pharmacokinetic profile of this regimen in these patients.
  • Investigate potential predictors of response by studying patient tissue specimens after receiving this regimen.

OUTLINE: This is a dose-escalation study of tirapazamine. Patients are stratified according to prior chemotherapy status (previously untreated vs previously treated).

Patients receive tirapazamine IV over 2 hours, paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes. Treatment continues every 21 days for a maximum of 8 courses in the absence of unacceptable toxicity or disease progression. Some patients may continue therapy in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients in the previously untreated stratum are treated at the MTD.

Patients are followed indefinitely.

PROJECTED ACCRUAL: A total of 36-68 patients (18-34 per stratum) will be accrued for this study within 12-18 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors
Study Start Date : March 2000
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced or metastatic malignant solid tumor not curable by resection or other standard therapy
  • No symptomatic brain metastases

    • Brain metastases allowed provided controlled with surgical excision and/or radiotherapy



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal


  • Creatinine normal
  • Creatinine clearance at least 60 mL/min


  • No New York Heart Association class III or IV congestive heart failure


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study
  • No history of allergic reactions to appropriate diuretics or antiemetics administered in conjunction with protocol chemotherapy (e.g., 5-HT3 antagonists)
  • No other concurrent uncontrolled illness that would preclude study therapy
  • No medical, social, or psychological factors that would preclude study therapy
  • No clinically significant hearing loss


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
  • No more than 2 prior chemotherapy regimens
  • No prior combination paclitaxel and carboplatin

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • At least 30 days since other prior investigational drugs
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005078

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Stephen Shibata, MD City of Hope Medical Center

Publications of Results:
Responsible Party: City of Hope Medical Center Identifier: NCT00005078     History of Changes
Other Study ID Numbers: 99139
U01CA062505 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000067685 ( Registry Identifier: NCI PDQ )
First Posted: May 16, 2003    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action