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Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
This study has been completed.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005078
  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 combining tirapazamine, carboplatin, and paclitaxel in treating patients who have advanced malignant solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: paclitaxel
Drug: tirapazamine
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Tirapazamine Paclitaxel Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors

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

Study Start Date: March 2000
Detailed Description:

OBJECTIVES:

  • 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.

  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 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • At least 30 days since other prior investigational drugs
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005078

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Beckman Research Institute
Investigators
Study Chair: James H. Doroshow, MD Beckman Research Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067685, CHNMC-PHI-22, CHNMC-IRB-99139, NCI-T99-0068
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005078     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Tirapazamine
Antimitotic Agents
Carboplatin
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Tirapazamine
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009