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I just though this might be of interest to someone since there are a few people going through high dose chemotherapy. They are using 3 drugs with little cross resistance to BEP / VIP which is a true step forward in the treatment of refractory germ ecll tumors. I know of one study out of Greece with a similar approach wich yeilded some good results concidering the patient group. This even offers hope for long term cure in those who have failed HD chemo with BMT.
Purpose
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.
This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
Condition Intervention Phase
Testicular
Extra Gonadal Germ Cell Neoplasm
Drug: Gemcitabine, oxaliplatin, paclitaxel
Phase II
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Endocrine Diseases; Testicular Disorders
Genetics Home Reference related topics: Cancer; Endocrine Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Further study details as provided by Norris Comprehensive Cancer Center:
Study start: November 2004
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
Must have refractory germ cell neoplasm defined as one or more of the following: [a] patients who progress during or within 4 wks of cisplatin-containing tx, OR [b] patients who have failed initial salvage chemotx regimens, including: high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP.
Must have one or more of the following (check all that apply): [a] Unidimensionally measurable dz assessed within 14 days prior to registration, OR [b] Elevated β-HCG >20 mIU assessed within 24-48 hrs prior to registration, OR [c] AFP >2 x uln assessed within 5-7 days prior to registration.
Note: Soft tissue dz, which has been radiated in the 2 mos prior to registration, is not assessable as measurable dz.
X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
May have received prior surgery or RT. At least 3 wks must have elapsed since completion of previous tx and must have recovered from any adverse effects.
Zubrod PS less than or equal to 2
greater than of equal to 16 yrs of age
AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
Total bilirubin <2.5 x uln; SGOT and alk phos <5 x uln (obtained within 14 days prior to registration)
LDH (obtained within 7 days prior to registration)
Creatinine <2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
Men of reproductive potential must agree to use effective contraceptive method
Signed informed consent (including HIPAA authorization)
Exclusion Criteria:
Prior tx with cytotoxic or experimental agents within 14 days prior to registration
Evidence of concurrent infection (T>96.8F but <101.5F; WBC <11.0 unless these values can be ascribed to another tumor-related phenomena)
Other prior malignancy, except adequately treated basal cell or squamous cell skin ca, adequately treated stage I or II ca from which patient is currently in CR, or any other ca from which patient has been disease-free for 5 yrs
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00183820
Omid Hamid, MD 323/865-0813 [email protected]
California
Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States; Recruiting
Omid Hamid, MD 323-865-0813 [email protected]
Study chairs or principal investigators
David Quinn, MD, Principal Investigator, Norris Comprehensive Cancer Center
Purpose
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.
This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
Condition Intervention Phase
Testicular
Extra Gonadal Germ Cell Neoplasm
Drug: Gemcitabine, oxaliplatin, paclitaxel
Phase II
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Endocrine Diseases; Testicular Disorders
Genetics Home Reference related topics: Cancer; Endocrine Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Further study details as provided by Norris Comprehensive Cancer Center:
Study start: November 2004
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
Must have refractory germ cell neoplasm defined as one or more of the following: [a] patients who progress during or within 4 wks of cisplatin-containing tx, OR [b] patients who have failed initial salvage chemotx regimens, including: high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP.
Must have one or more of the following (check all that apply): [a] Unidimensionally measurable dz assessed within 14 days prior to registration, OR [b] Elevated β-HCG >20 mIU assessed within 24-48 hrs prior to registration, OR [c] AFP >2 x uln assessed within 5-7 days prior to registration.
Note: Soft tissue dz, which has been radiated in the 2 mos prior to registration, is not assessable as measurable dz.
X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
May have received prior surgery or RT. At least 3 wks must have elapsed since completion of previous tx and must have recovered from any adverse effects.
Zubrod PS less than or equal to 2
greater than of equal to 16 yrs of age
AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
Total bilirubin <2.5 x uln; SGOT and alk phos <5 x uln (obtained within 14 days prior to registration)
LDH (obtained within 7 days prior to registration)
Creatinine <2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
Men of reproductive potential must agree to use effective contraceptive method
Signed informed consent (including HIPAA authorization)
Exclusion Criteria:
Prior tx with cytotoxic or experimental agents within 14 days prior to registration
Evidence of concurrent infection (T>96.8F but <101.5F; WBC <11.0 unless these values can be ascribed to another tumor-related phenomena)
Other prior malignancy, except adequately treated basal cell or squamous cell skin ca, adequately treated stage I or II ca from which patient is currently in CR, or any other ca from which patient has been disease-free for 5 yrs
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00183820
Omid Hamid, MD 323/865-0813 [email protected]
California
Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States; Recruiting
Omid Hamid, MD 323-865-0813 [email protected]
Study chairs or principal investigators
David Quinn, MD, Principal Investigator, Norris Comprehensive Cancer Center
I'm gonna keep my eye on this one.
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