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Chemotherapy in Treating Patients With 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: NCT00003103
Recruitment Status : Completed
First Posted : April 6, 2004
Last Update Posted : July 3, 2013
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of oblimersen in treating patients who have solid tumors that have not responded to previous therapy.

Condition or disease Intervention/treatment Phase
Bladder Cancer Breast Cancer Colorectal Cancer Esophageal Cancer Head and Neck Cancer Kidney Cancer Lung Cancer Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific Biological: oblimersen sodium Drug: docetaxel Phase 1 Phase 2

Detailed Description:

OBJECTIVES: I. Evaluate the safety and plasma concentration profiles of oblimersen (G3139) administered alone or in combination with docetaxel in patients with advanced solid tumors expressing the bcl-2 oncogene. II. Determine the plasma concentration profiles, maximum tolerated dose (MTD), and/or optimal biologic dose (OBD) of this treatment regimen in these patients. III. Determine the antitumor effects of G3139, at the MTD or OBD, in combination with docetaxel in patients with androgen-independent, refractory, or recurrent prostate cancer.

OUTLINE: This is a dose-escalation study of oblimersen (G3139). Phase I: Patients receive G3139 IV on days 1-5 and docetaxel IV on day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive G3139 continuously over 21 days at one dose level below the MTD in combination with weekly docetaxel. Patients receive up to 2 more courses of therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A maximum of 57 patients (42 for phase I and 15 for phase II) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Primary Purpose: Treatment
Official Title: A Phase I/IIA Dose-Escalating Trial of BCL-2 Antisense (G3139) Treatment for Patients With Androgen-Independent Prostate Cancer or Other Advanced Solid Tumor Malignancies
Study Start Date : August 1997
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS: Phase I: Histologically proven advanced, primary, or malignant solid tumors that are refractory to standard therapy or for which no curative therapy exists Androgen-independent prostate cancer Head and neck cancers Breast cancer Non-small cell lung cancer Colorectal cancer Ovarian cancer Esophageal cancer Bladder cancer Kidney cancer Other solid tumors Metastatic disease should not require palliative treatment within 4 weeks of enrollment Phase II: Histologically proven androgen-independent prostate cancer Serum testosterone less than 30 ng/mL Failed at least one prior chemotherapy regimen Progressive Minimum of 3 rising PSA values from baseline obtained at least 1 week apart OR Two rising PSA values more than one month apart AND At least 25% increase over range of values AND PSA at least 4 ng/mL No active CNS or epidural tumor Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times the upper limit of normal Prothrombin time less than 14 seconds Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV cardiac disease Pulmonary: No severe debilitating pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection No other severe medical problems

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Concurrent medical therapy (i.e., gonadotropin releasing hormone analogs or diethylstilbestrol) to maintain castrate levels of serum testosterone allowed No other concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy to localized sites of disease not being evaluated in study allowed Surgery: Not specified Other: At least 4 weeks since prior investigational anticancer therapy and recovered No concurrent intravenous antibiotics

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): NCT00003103

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00003103    
Other Study ID Numbers: 97-096
CDR0000065836 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 6, 2004    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
recurrent Wilms tumor and other childhood kidney tumors
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Kidney Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Esophageal Diseases
Kidney Diseases
Antineoplastic Agents