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


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

OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive
docetaxel IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days
1, 4, 8, and 11. Treatment continues every 3 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231
and docetaxel 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 Gilbert's syndrome PT and aPTT normal SGOT or SGPT less than
3 times ULN 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 Adequate venous access No known hypersensitivity to
docetaxel or any oligodeoxynucleotides No prior peripheral neuropathy greater than grade 2
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 other 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:

CDR0000067520

NCT ID:

NCT00004864

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