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A Phase I Open-Label Safety Study of Escalating Doses of Taxol in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors


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

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Trial Information

A Phase I Open-Label Safety Study of Escalating Doses of Taxol in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors


OBJECTIVES: I. Determine the safety and maximum tolerated dose of GEM 231 and paclitaxel in
patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor
activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of GEM 231. Patients receive paclitaxel IV over 3
hours on day 1, immediately followed by GEM 231 over 2 hours on days 1, 4, 8, 11, 15, and
18. Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients are treated with one of two doses of paclitaxel and
escalating doses of GEM 231 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the
maximum tolerated dose is reached.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor that is refractory
to standard therapy or for which no standard therapy exists Measurable or evaluable
disease No CNS metastases that are untreated, associated with seizures, or require
intravenous medication and/or hospitalization

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hemoglobin at least 8.5 g/dL Hepatic: Bilirubin no greater than upper
limit of normal (ULN), except with Gilbert's syndrome (no greater than 1.5 times ULN if
liver metastases present) PT and aPTT normal SGOT or SGPT less than 3 times ULN (no
greater than 5 times ULN if liver metastases present) Renal: Creatinine less than 1.25
times ULN No renal tubular dysfunction (i.e., at least 2+ proteinuria within the past 2
weeks) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception for 1 month prior to, during, and 3 months after study No other
serious medical condition that would prevent compliance No serious infection No known
hypersensitivity to paclitaxel or other drugs formulated in Cremophor or any
oligodeoxynucleotides Adequate venous access No psychological or geographical condition
that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior transfusion Prior
biologic therapy allowed and recovered No concurrent biologic therapy Chemotherapy: Prior
chemotherapy allowed and recovered No other concurrent chemotherapy Endocrine therapy:
Prior hormonal therapy allowed and recovered Concurrent palliative hormonal therapy
allowed Radiotherapy: Prior radiotherapy allowed and recovered No concurrent radiotherapy
(except palliative) Surgery: At least 2 weeks since prior major surgery with wound
complications Other: At least 2 weeks since prior investigational drugs No other
investigational drugs during or within 28 days of study No concurrent CYP-3A metabolism
dependent drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sridhar Mani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Federal Government

Study ID:

CDR0000067518

NCT ID:

NCT00004863

Start Date:

July 1999

Completion Date:

Related Keywords:

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

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461