Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Teratoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Germ Cells Tumors

Ovarian Germ Cell Tumor

Malignant Germ Cell Tumor

Extragonadal Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Micronutrients

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Etoposide

Cyclophosphamide

Carboplatin

Doxorubicin

Liposomal doxorubicin

Leucovorin

Levoleucovorin

Methotrexate

Vincristine

Calcium

Lenograstim

Dactinomycin

Etoposide phosphate

Calcium, Dietary

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antidotes

Protective Agents

Trace Elements

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

dactinomycin

filgrastim

carboplatin

cyclophosphamide

doxorubicin hydrochloride

etoposide

leucovorin calcium

methotrexate

vincristine sulfate

conventional surgery

Norma Wollner, MD

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 II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors.

OBJECTIVES: I. Determine the efficacy of cyclophosphamide, carboplatin, and etoposide in patients with non-testicular malignant germ cell tumors. II. Improve the quality of life of these patients by shortening the length of treatment and the extent of initial surgical resection. III. Determine whether histologic subtypes have prognostic significance. IV. Determine the efficacy of short term chemotherapy in this patient population. V. Determine the role of second look surgery in predicting curability of non testicular germ cell tumors. VI. Determine the role of dose intensification of cyclophosphamide and the introduction of doxorubicin, methotrexate, and dactinomycin for those patients with partial response, no response, or progressive disease at the time of second look surgery.

OUTLINE: Patients undergo treatment on Regimen A consisting of surgical resection of tumor as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes on day 1, carboplatin IV on day 2, and etoposide IV on days 2-4. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24-48 hours following the last dose of etoposide and continuing for 14 days or until blood counts recover (a total of 28 days). Chemotherapy repeats every 3 weeks for 4 courses in the absence of disease progression. At week 11, patients undergo second look surgery to evaluate response and resect any residual disease. Patients with no residual disease receive no further therapy. Patients with good partial response or no response receive salvage chemotherapy on Regimen B. Patients receive salvage chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3, doxorubicin IV and vincristine IV continuously on days 1-3, and G-CSF SQ daily beginning 24-48 hours following last dose of vincristine and continuing for 14 days or until blood counts recover. At week 3, patients receive cyclophosphamide IV on days 1-2, vincristine IV and doxorubicin IV continuously on days 1-3 and G-CSF as previously given in Regimen B. At week 6, patients receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3 days, beginning 16 hours after the completion of methotrexate. At week 8, salvage chemotherapy repeats for an additional course. Patients achieving complete response following salvage chemotherapy receive no further therapy. Patients with no response are removed from study.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study over 6 years.

Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors

PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS

Memorial Sloan Kettering Cancer Center

Digestive System Diseases

Skin and Connective Tissue Diseases

Carcinoma

Adenocarcinoma

Endodermal Sinus Tumor

Sarcoma

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Cystadenocarcinoma

Carcinoma, Embryonal

Choriocarcinoma

Brenner Tumor

Dysgerminoma

Cystadenocarcinoma, Mucinous

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Germinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

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

Neoplasms, Connective and Soft Tissue

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Endometrial Neoplasms

Uterine Neoplasms

Trophoblastic Neoplasms

Pregnancy Complications, Neoplastic

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Embryonal Carcinoma

Brenner Tumor of Ovary

Polyembryoma

Central Nervous System Germinoma

Testicular Yolk Sac Tumor

Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale, FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at 3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of chemotherapy.

Cognitive Assessment

Quality-of-Life Assessment

Lisa Hess

This clinical trial is studying changes in brain function in patients with stage I, stage II, stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.

PRIMARY OBJECTIVE:

I. To describe changes in cognitive function among patients with ovarian, primary peritoneal, or fallopian tube cancer receiving front-line chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder Customized Research Tool (CRT).

SECONDARY OBJECTIVES:

I. To estimate the proportion of these patients who experience possible or probable acute or persistent impairment in cognitive function while receiving chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder CRT.

II. To explore the association between the patient-reported neurocognitive function as measured by the Patient Assessment of Own Functioning (PAF) scale and web-based assessment of cognitive function as measured by the HeadMinder CRT.

TERTIARY OBJECTIVES:

I. To explore the relationship between patient-reported quality of life as measured by the FACT-O and cognitive function as measured by the web-based and patient-reported assessments, respectively. (Exploratory) II. To explore whether the patient-reported cognitive function or the web-based assessment of cognitive function is associated with anxiety and depression as measured by the Hospital Anxiety and Depression Scale. (Exploratory) III. To explore the changes in cognitive function using the web-assessed (CRT) and self-reported (PAF) assessments, respectively, among patients with advanced ovarian cancer (stage III-IV, optimally debulked disease at enrollment) receiving IV as compared to intraperitoneal treatment. (Exploratory) IV. To explore whether the cognitive impairment as measured with web-based assessment is associated with patient age, hemoglobin, platelet count, patient-reported neurotoxicity symptoms as measured with FACT/GOG-Ntx subscale, or body weight. (Exploratory)

OUTLINE: This is a multicenter study.

Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale, FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at 3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of chemotherapy.

Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy

A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer

National Cancer Institute (NCI)

Gynecologic Oncology Group

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Recurrence

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Nasopharyngeal Carcinoma

Mouth Neoplasms

Testicular Neoplasms

Kidney Neoplasms

Rhabdoid Tumor

Sarcoma, Clear Cell

Stomach Cancer

Esophageal Cancer

Renal Cell Carcinoma

Small Cell Lung Cancer

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Testicular Germ Cell Tumor

Uterine Sarcoma

Metastatic Squamous Neck Cancer With Occult Primary

Paclitaxel

Albumin-Bound Paclitaxel

paclitaxel albumin-stabilized nanoparticle formulation

gene expression analysis

laboratory biomarker analysis

pharmacological study

polymerase chain reaction

Sridhar Mani, MD

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors.

OBJECTIVES:

Primary

* To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent.

Secondary

* To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer (castrate), metastatic breast cancer, advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel.
* To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia.
* To explore the association between the CYP2C8\*3 variant and paclitaxel clearance.
* To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4, CYP3A5, SLCO1B3 (OATP8), and ABCB1 (MDR1) and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) IV over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment may repeat off study every 9 weeks in the absence of disease progression or unacceptable toxicity.

Serial blood samplings are obtained at specified time points during course 1 including baseline and days 1 and 8 of course 1 for pharmacokinetic studies. Samples are also examined for genotype by PCR including variant genotypes in 2C8, CYP3A4, CYP3A5, ABCB1, ABCC2, ABCC10 and OATP1B3 genes.

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors	NCT00002489	Extragonadal Ge... Ovarian Cancer	dactinomycin filgrastim carboplatin cyclophosphamid... doxorubicin hyd... etoposide leucovorin calc... methotrexate vincristine sul... conventional su...	- 20 Years	Memorial Sloan Kettering Cancer Center
Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors	NCT00002489	Extragonadal Ge... Ovarian Cancer	dactinomycin filgrastim carboplatin cyclophosphamid... doxorubicin hyd... etoposide leucovorin calc... methotrexate vincristine sul... conventional su...	- 20 Years	Memorial Sloan Kettering Cancer Center
Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy	NCT01080521	Cognitive Side ... Malignant Ovari... Ovarian Brenner... Ovarian Carcino... Ovarian Chorioc... Ovarian Clear C... Ovarian Dysgerm... Ovarian Embryon... Ovarian Endomet... Ovarian Mixed G... Ovarian Mucinou... Ovarian Polyemb... Ovarian Sarcoma Ovarian Seromuc... Ovarian Serous ... Ovarian Teratom... Ovarian Yolk Sa... Stage I Ovarian... Stage IA Fallop... Stage IA Ovaria... Stage IA Ovaria... Stage IB Fallop... Stage IB Ovaria... Stage IB Ovaria... Stage IC Fallop... Stage IC Ovaria... Stage IC Ovaria... Stage II Ovaria... Stage IIA Fallo... Stage IIA Ovari... Stage IIA Ovari... Stage IIB Fallo... Stage IIB Ovari... Stage IIB Ovari... Stage IIC Fallo... Stage IIC Ovari... Stage IIC Ovari... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIA Ovar... Stage IIIA Prim... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIB Ovar... Stage IIIB Prim... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Ovar... Stage IIIC Prim... Stage IV Fallop... Stage IV Ovaria... Stage IV Ovaria... Stage IV Primar... Undifferentiate...	Cognitive Asses... Quality-of-Life...	18 Years -	GOG Foundation
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors	NCT00499291	Cancer	paclitaxel albu... gene expression... laboratory biom... pharmacological... polymerase chai...	18 Years - 120 Years	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for ovarian teratoma