Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Transitional Cell

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Brenner Tumor

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

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

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Neoplasms, Cystic, Mucinous, and Serous

Endometrial Neoplasms

Uterine Neoplasms

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Transitional Cell Carcinoma

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Brenner Tumor of Ovary

Patients undergo collection of serum samples for analysis of YKL-40 via ELISA and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Katherine Bell-McGuinn

This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To assess the ability of the YKL-40 serum marker to detect response or lack of response to primary chemotherapy in International Federation of Gynecology and Obstetrics (FIGO) stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

II. To compare the predictive accuracy of YKL-40 with cancer antigen 125 (CA125).

SECONDARY OBJECTIVES:

I. To test the ability of the YKL-40 serum marker to detect recurrence of ovarian, primary peritoneal, or fallopian tube cancer in patients who are in first remission following primary chemotherapy.

II. To test the ability of the YKL-40 serum marker to predict poor risk patients with FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

TERTIARY OBJECTIVES:

I. To explore alternative cut-off values for YKL-40 elevation in this large patient population.

II. To describe the variability of YKL-40 and CA125 measurements in patients receiving primary chemotherapy and in primary remission in a large patient population.

III. To describe the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response, progression-free survival and overall survival.

OUTLINE:

Patients undergo collection of serum samples for analysis of YKL-40 via enzyme-linked immunosorbent assay (ELISA) and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.

YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

A Prospective, Longitudinal Study of YKL-40 in Patients With FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer Undergoing Primary Chemotherapy

As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described.

Optimal cut-off values for YKL-40 that subsequently can be used in clinical practice will be determined. Any statistical significance calculated for an optimized cut-off will adjust for the selection process, and any comparison with CA-125 will treat both markers in the same way.

As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting overall survival will be described.

As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting progression-free survival will be described.

Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of CA125 over time in this population.

Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of YKL-40 over time in this population.

The accuracy of each marker alone will be compared using area under the ROC curve, and assess which adds more predictive information when both are included in logistic regression.

In order to make a valid comparison between CA125 and YKL-40, in this study computed tomography (CT) criteria will be treated as the "gold standard" and whether changes in YKL-40 levels correlate with CT evidence as well as or better than changes in CA125 levels will be evaluated.

Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.

Parallel analyses of the markers as predictors of time-to-relapse will be performed using survival-type regression methods such as the Cox proportional hazards model or a parametric maximum likelihood model. The total number of patients available for analysis of time to relapse is the number of patients who respond to treatment.

YKL-40 will be compared to CA125 in terms of its ability to detect response to chemotherapy (during chemotherapy) and recurrence of disease (in remission). Serum YKL-40 behavior will also be assessed as a reflection of tumor histology, tumor grade, and tumor stage-all in comparison to CA125. The accuracy of each marker alone will be compared using area under the receiver operating characteristic (ROC) curve, and assess which adds more predictive information when both are included in logistic regression.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Immune System Diseases

Melanoma

Carcinoma, Squamous Cell

Hypersensitivity

Carcinosarcoma

Mixed Tumor, Mullerian

Melanoma, Cutaneous Malignant

Carcinoma, Adenosquamous

Adenosarcoma

Adenoma, Pleomorphic

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Sarcoma

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Carcinosarcoma

Adenosquamous Carcinoma of the Endometrium

Neuroendocrine Tumor

Neuroepithelioma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

Nab-paclitaxel

Pharmacological Study

Matthew S. Block, M.D., Ph.D.

This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow tumor growth by blocking the growth of new blood vessels necessary for tumor growth. Giving nab paclitaxel and bevacizumab may kill more tumor cells than nab-paclitaxel alone.

PRIMARY OBJECTIVES:

I. To determine the maximally tolerated dose (MTD-malignant melanoma \[MM\]) of Abraxane (nab-paclitaxel)/bevacizumab-complex (AB-complex) among patients with metastatic malignant melanoma.

II. To determine the maximally tolerated dose (MTD-gynecologic \[GYN\]) of AB-complex among patients with gynecologic cancers.

III. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously-treated endometrial cancer IV. To further assess the safety profile and anti-tumor activity of the recommended phase II dose of AB-complex for patients with previously treated ovarian cancer

SECONDARY OBJECTIVES:

I. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with metastatic malignant melanoma.

II. To gather preliminary data on tumor response rate and progression free survival time of AB-complex among patients with gynecologic cancers.

CORRELATIVE OBJECTIVES (DOSE-ESCALATION COHORTS ONLY):

I. Pharmacokinetics of paclitaxel administered in the context of AB-complex. II. Tumor concentrations of paclitaxel 24 hour (h) following AB-complex infusion and correlation with plasma levels.

OUTLINE: This is a dose-escalation study.

Patients receive nab-paclitaxel/bevacizumab-complex intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.

After completion of study treatment, patients are followed up every 6 months for 12 months.

Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers

Targeted Complex Therapy for Advanced Melanoma, Gynecologic Cancers, and Other Malignancies: Nab-Paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex)

Defined as the highest dose level among those under consideration where at most 1 of 6 patients develops a dose-limiting toxicity. The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.

Defined as complete response or partial response on 2 consecutive evaluations at least 8 weeks apart. Will be assessed as the number of patients whose tumor has met the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria. A 90% binomial confidence interval for the tumor response rate will be determined.

The maximum grade of each type of adverse event will be recorded for each patient and the percentage of patients developing any degree of that adverse effect as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy	NCT00899093	Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Ovarian Adenoca... Primary Periton... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIA Prim... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIB Prim... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Prim... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar... Undifferentiate... Undifferentiate...	Cytology Specim... Laboratory Biom...	18 Years -	GOG Foundation
Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers	NCT02020707	Cervical Adenoc... Cervical Adenos... Cervical Adenos... Cervical Carcin... Cervical Squamo... Clinical Stage ... Endometrial Ade... Endometrial Cle... Endometrial End... Endometrial Mix... Endometrial Muc... Endometrial Ser... Endometrial Und... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Femal... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Ovari... Malignant Perit... Malignant Solid... Ovarian Carcino... Ovarian Clear C... Ovarian Endomet... Ovarian High Gr... Ovarian Mucinou... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Platinum-Resist... Platinum-Resist... Platinum-Resist... Platinum-Sensit... Primary Periton... Primary Periton... Primary Periton... Primary Periton... Primary Periton... Unresectable Me... Uterine Corpus ...	Bevacizumab Laboratory Biom... Nab-paclitaxel Pharmacological...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for malignant ovarian mucinous tumor