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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004863
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : October 26, 2010
National Cancer Institute (NCI)
Information provided by:
Montefiore Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: GEM 231 Drug: paclitaxel Phase 1

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.

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : July 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004863

United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
National Cancer Institute (NCI)
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine, Inc. Identifier: NCT00004863     History of Changes
Other Study ID Numbers: CDR0000067518
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2004    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

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

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action