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Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen Shibata, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

99139

NCT ID:

NCT00005078

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Medical CenterDuarte, California  91010
City of Hope Medical GroupPasadena, California  91105