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Study Summary
No. 2005-0479:.......Breast; Lung; Prostate......Razelle Kurzrock......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2005-0479
Study Title:A Phase I Trial of Amplimexon (imexon for inj.) plus Taxotere (docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
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Physician New Patient Referral
Name:Razelle KurzrockPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-1226
Contact us about clinical trials
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General Information
Disease Group:Breast
Lung
Prostate
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Cycle 1 patients will come to MDACC days 1 - 5, 8, and 15. Cycle 2 and beyond
patients will come to MDACC days 1 - 5 and 15. Patients will return 15 - 30
days after the last dose of drug, then 3 and 6 months after the last dose of
drug.
Treatment
Agents:
Amplimexon
Docetaxel
Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of the new drug Amplimexon (imexon Inj.) than can be given with the
chemotherapy drug docetaxel in patients with NSCLC, breast cancer, or prostate
cancer. The safety and effectiveness of this combination will also be studied.
Researchers want to learn if patients' glutathione (thiol) levels in the blood
are decreased by Amplimexon and if the decrease is related to how well the drug
may work on your cancer.
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Study Objectives / Outcomes
Primary Objectives:
  • Determine the tolerability, the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of increasing doses of Amplimexon in combination with standard doses of docetaxel in patients with previously treated inoperable stage III or stage IV non-small cell lung cancer (NSCLC), locally advanced or metastatic previously treated breast cancer or hormone refractory prostate cancer.
  • Correlate changes in plasma glutathione (GSH) levels with Amplimexon dose levels

Secondary Objectives:
  • Record any objective tumor responses that may occur.
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Study Status Information
Study Activation / Registration Date:09/07/2005
IRB Review and Approval Date:07/20/2005
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) This study is open to previously treated patients with locally advanced or metastatic NSCLC, locally advanced or metastatic breast cancer and metastatic prostate cancer for whom Taxotere is an appropriate treatment. This includes breast cancer patients after failure of prior chemotherapy, NSCLC patients after failure of prior platinum-based chemotherapy, and prostate cancer patients who are hormone refractory. There is no limit on the number of prior chemotherapy regimens, provided all other eligibility criteria are met.

2) Measurable or evaluable (non-measurable) disease

3) ECOG performance status 0 - 2

4) Age >/= 18 years

5) Prior docetaxel therapy is permitted.

6) If female, neither pregant (negative pregnancy test) nor lactating

7) If of child-bearing potential, must be able and agree to use adequate contraception

8) Concomitant disease: no respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life-threatening ventricular arrhythmias; no current or past history of congestive heart failure (patients with a past history or current history of any heart disease including: aneurysms, arrhythmias, atherosclerotic coronary artery disease, cardiomyopathies, heart failure of any cause, pericardial diseases, valvular heart diseases, infectious heart diseases,

9) (contingued from Inclusion #8) inflammatory heart disease, congenital heart disease, myocardial infarction, angina, abnormal EKG, or systemic atherosclerotic disease such as stroke or TIA shall have a MUGA scan with an ejection fraction within the normal limits of the testing institution.

10) No other concurrent active malignancy requiring treatment

11) Off all anticancer therapy for greater than or equal to 4 weeks. This includes surgery, chemotherapy, and radiation.

12) Prior radiotherapy is permitted, but only if to less than an estimated 25% of the bone marrow.

13) No infection requiring parenteral antibiotic therapy concurrent with the study drug

14) No effusions or chronic fluid retention

15) Patients must be off systemic steroids for a minimum of 2 weeks, except in the case of patients with prostate cancer who will be treated with prednisone 5 mg po bid during the protocol therapy. Inhaled steroids are allowed. The standard prophylactic corticosteroid therapy for the prevention of acute reactions to docetaxel will also be used.

16) Lab values within the following criteria: hgb >/= 9 gm/dL; ANC >/= 1,500/mm^3; plt >/= 100,000/mm^3; creatinine </= 1.5 x upper limit of normal (ULN); bilirubin </= ULN; AST, ALT </= 1.5 x ULN; alkaline phosphatase </= 1.5 x ULN; G6PD >/= lower limit of normal

17) Able to render informed consent and to follow protocol requirements

Exclusion Criteria:1) ECOG performance status greater than 2

2) Age < 18 years

3) Any prior hypersensitivity reaction to taxanes or other drugs containing polysorbate 80

4) Patients must not be taking drugs which inhibit cytochrome P450 3A4, including cyclosporine, erythromycin, ketoconazole, terfenidine, or troleandomycin. These drugs must not be taken within 48 hours of initiation of treatment.

5) Patients who cannot avoid taking acetaminophen or acetaminophen containing combination medication during Ampimexon treatment

6) Current active brain metastases. Patients with a history of brain metastases must have completed treatment for them at least 1 month previously and must be free of symptoms and off systemic steroids for >/= 2 week weeks, or must have small (< 1 cm) brain metastases that are asymptomatic and do not require immediate cranial radiation.

7) If female, pregnant or lactating

8) Unable to unwilling to utilize contraception if of childbearing potential

9) Respiratory insufficientcy requiring oxygen therapy; angina at rest; myocardial infarction within the prior 3 months; life-threatening arrhythmias and congestive heart failure

10) Prior therapy within last 4 weeks (chemotherapy, surgery, radiation therapy)

11) Infection requiring parenteral antibiotics

12) Large pleural effusions or clinically significant chronic fluid retention

13) Ejection fraction below the lower limit of normal in patients required to have a MUGA scan.

14) Laboratory parameters outside of acceptable ranges

15) Unable to render informed consent

16) Failure to meet any of the eligibility criteria

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Links
Registration Number: NCT00327288
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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