Paclitaxel 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:
NCT00004863
First received: March 7, 2000
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of paclitaxel 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: paclitaxel
Phase 1

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

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 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.

  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 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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004863

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: NCT00004863     History of Changes
Other Study ID Numbers: CDR0000067518, P30CA013330, AECM-1199906196, HYBRIDON-231-100B, NCI-G00-1665
Study First Received: March 7, 2000
Last Updated: October 25, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 22, 2014