Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Testicular Neoplasms

Seminoma

Neoplasms, Germ Cell and Embryonal

Germinoma

Ovarian Neoplasms

Disease Attributes

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Germ Cells Tumors

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Testicular Seminoma

Nonseminomatous Germ Cell Tumor

Extragonadal Germ Cell Tumor

Central Nervous System Germinoma

Ovarian Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Bone Density Conservation Agents

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Folic Acid

Calcium, Dietary

Alvocidib

Vitamin B Complex

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Alvocidib Hydrochloride

Leucovorin Calcium

Darren Feldman

This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate the antitumor efficacy of the combination of flavopiridol and oxaliplatin with or without 5-FU and leucovorin in patients with relapsed or refractory GCT. The necessity of 5-FU and leucovorin to the combination will also be indirectly tested in this study.

SECONDARY OBJECTIVES:

I. To further evaluate the safety of flavopiridol in combination with oxaliplatin with or without 5-fluorouracil and leucovorin in patients with refractory or relapsed GCT.

II. To evaluate the time to tumor response (TTR) and progression-free survival for patients with refractory or relapsed GCT treated with flavopiridol in combination with oxaliplatin with or without 5-fluorouracil and leucovorin.

III. To explore the association between treatment response and p21, p53 and apoptotic markers.

OUTLINE: Patients are initially enrolled in part A (closed to accrual as of 11/15/2010). Depending on response to treatment, additional patients may be enrolled in part B.

PART A (alvocidib and oxaliplatin) (closed to accrual as of 11/15/2010): Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

PART B (alvocidib and FOLFOX): Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Tumor tissue samples may be collected periodically for further laboratory analysis.

After completion of study treatment, patients are followed up every 4-8 weeks.

Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors

A Non-randomized Phase 2 Study of Alvocidib (Flavopiridol) Plus Oxaliplatin With or Without 5-FU and Leucovorin for Relapsed or Refractory Germ-Cell Tumors

graded using the NCI CTCAE version 4.0.See adverse event section

Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

National Cancer Institute (NCI)

Part A (Alvocidib and Oxaliplatin)

Part B (Alvocidib and FOLFOX)

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Darren Feldman

Partial Response

Stable Disease

Progression of Disease

Objective Response Rate

Toxicity

Progression-free Survival

Time to Tumor Response

6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.

Part A

6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 \& 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 \& 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 \& 29.

5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 \& 29-30.

Part B

Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months

Biomarker analysis

Mette Pernille Myklebust, PhD

Olav Dahl, PhD

Bogdan Stefan Bercea, MD

Helene Negaard, MD, PhD

Hege S. Haugnes, MD, PhD

Anna G. Bergdahl, MD, PhD

Anna Thor, MD

Anders Kjellman, MD, PhD

The main objective of this study is establish the performance of miR371 in management of testicular cancer

The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Blood is collected in order to extract RNA.

MicroRNA as Markers in Testicular Cancer

MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours

To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis

To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND

To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors	NCT00957905	Recurrent Extra... Recurrent Malig... Recurrent Malig... Recurrent Malig... Recurrent Ovari... Stage III Testi... Stage IV Extrag... Stage IV Extrag... Stage IV Ovaria...	Alvocidib Hydro... Fluorouracil Leucovorin Calc... Oxaliplatin	18 Years -	National Cancer Institute (NCI)
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors	NCT00957905	Recurrent Extra... Recurrent Malig... Recurrent Malig... Recurrent Malig... Recurrent Ovari... Stage III Testi... Stage IV Extrag... Stage IV Extrag... Stage IV Ovaria...	Alvocidib Hydro... Fluorouracil Leucovorin Calc... Oxaliplatin	18 Years -	National Cancer Institute (NCI)
MicroRNA as Markers in Testicular Cancer	NCT04914026	Testicular Germ... Seminoma Non-Seminoma Te... Stage I Testicu... Stage II Testic... Stage III Testi... Stage IV Testic... Relapse Testicu...	Biomarker analy...	18 Years - 70 Years	Haukeland University Hospital

Spots Global Cancer Trial Database for stage iii testicular cancer