Docetaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00004864
First received: March 7, 2000
Last updated: December 29, 2011
Last verified: July 2008
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells and make the tumor more sensitive to chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: GEM 231
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Study Start Date: July 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004864

Locations
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004864     History of Changes
Other Study ID Numbers: CDR0000067520, P30CA013330, AECM-1199906197, HYBRIDON-231-100A, NCI-G00-1666
Study First Received: March 7, 2000
Last Updated: December 29, 2011
Health Authority: United States: Federal Government

Keywords provided by Montefiore Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014