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Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic 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 Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with
locally advanced or metastatic solid tumors.

- Determine the dose-limiting toxic effects of this regimen in these patients.

Secondary

- Determine the toxicity profile of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and
8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine 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.

Patients are followed for survival every 3 months after completion of study therapy.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed locally advanced or metastatic solid tumors

- Minimally pretreated

- Not refractory to prior gemcitabine therapy

- No disease progression during initial treatment with gemcitabine

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are
present)

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- Ejection fraction at least 40% by MUGA

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric disorder that would preclude study consent or compliance

- No concurrent severe or uncontrolled underlying medical disease unrelated to the
tumor that would compromise patient safety or affect study outcome

- No hypersensitivity to gemcitabine

- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
unless in complete remission and off all therapy for that disease for at least 2
years

- No serious infection

- No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent anticancer biologic therapy

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No other concurrent anticancer chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Recovered from prior radiotherapy

- No concurrent anticancer radiotherapy

- Concurrent localized palliative radiotherapy to a non-indicator lesion for pain
control allowed only if other methods of pain control are ineffective

Surgery

- At least 4 weeks since prior major surgery and recovered

Other

- More than 28 days since prior investigational drugs, including analgesics or
antiemetics

- At least 4 weeks since prior myelosuppressive therapy

- No other concurrent anticancer therapy

- No other concurrent anticancer cytotoxic therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000339345

NCT ID:

NCT00072228

Start Date:

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032