Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Taxane

Alkylating Agents

Antimitotic Agents

Tubulin Modulators

BIIB022 in Combination with Paclitaxel and Carboplatin

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

BIIB022 With Paclitaxel and Carboplatin

The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer

Biogen

Therese Senta-McMillian, Clinical Team Manager

Symptoms and General Pathology

Neoplasm Metastasis

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Carboplatin AUC5 IV Day 1 Pazopanib in escalating dosages, 200 mg to 800 mg starting on days 2 or 3 and ending on days 19 or 21

Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.

Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.

Pazopanib

Montasur Shaheen, MD

This study is designed to investigate the possibility that use of two similar but distinct drugs used together in treatment of advanced cancer might prove less toxic than either agent used alone, because dosages can be reduced for each agent. This is a phase I study that is designed to measure the frequency and levels of specific side effects when Carboplatin and Pazopanib are used in combination in advanced cancer patients. The possibility that anti-tumor activity will occur is also going to be investigated.

Pazopanib has shown a promising anti-cancer activity as a single agent tyrosine kinase inhibitor. Activity against multiple tumors such as renal cell carcinoma (RCC) and neuroendocrine tumors have been documented, and it recently gained FDA approval for the treatment of metastatic kidney cancer. Also, an impressive activity as a single agent was recently reported in non-small cell lung cancer (NSCLC) in the neoadjuvant setting, where tumor shrinkage occurred in 86% of patients. Encouraging activity has also been seen in cervical cancer, ovarian cancer and soft tissue sarcomas. Multi-kinase targeting is an approach that may prove beneficial in a number of patient populations. In particular cancers such as breast, colon, pancreas etc., patients represent heterogeneous population of small groups based on genetic analyses. Some of these populations may benefit when multiple agents are given which have similar, but distinct targets of action. Dosages and therefore associated toxicities might be reduced by such an approach.

A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

A Phase I Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies

Patients will receive 200mg of Pazopanib, with later subjects receiving higher dosages up to 800mg of Pazopanib. If a given dose level is not well tolerated when given on all days (1-21) of each cycle, the study will no longer use that dosage. Later subjects may take Pazopanib from days 3-19 of the three week cycle to see if that dosing schedule is better tolerated.

If patients experience side effects from Pazopanib or tests indicate some undesirable effects, then the dose level of Pazopanib that they are receiving may need to be adjusted, with increased monitoring.

GlaxoSmithKline

New Mexico Cancer Care Alliance

Hormones

Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.

Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.

Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility

Clarisa R Gracia, MD, MSCE

Women of late to mid reproductive age may participate in a study using novel methodology to identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis, which may have important implications for reproduction and may signal reproductive senescence.

Women with a reduced follicular pool either from natural aging or previous chemotherapy, may not have any clinical signs or symptoms and traditional measures of ovarian reserve, such as basal Follicle Stimulating Hormone may be within the normal range. However, there may be alterations in the luteal or follicular phases(shortened follicular phase and luteal insufficiency) due to compromised follicle competency and alterations in the H-P-O axis. Therefore this aim uses novel methodology to identify subtle changes in the reproductive endocrine axis which may have important implications for reproduction and may signal reproductive senescence. Compared to yearly follicular measures of reproductive hormones, daily urine hormone analysis provides a more integrative assessment.

Three groups of subjects will be recruited:

Group 1: Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.

Group 2: healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.

Group 3: healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility.

Subjects in all groups must have regular menstrual cycles every 21-35 days, and have a uterus and both ovaries. Each participant will complete daily urinary collections for 2 menstrual cycles to assess reproductive hormones. The ultimate goal of this work is to better estimate the reproductive window, or time to menopause.

daily urinary collections for 2 menstrual cycles

Assessing Urinary Hormones in Female Cancer Survivors

Follicular and Luteal Dysfunction in Cancer Survivors

Integrated urinary follicular-phase Follicle Stimulating Hormone (FSH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.

Integrated urinary follicular-phase Luteinizing Hormone (LH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.

Estrone Conjugate (E1C) in urine samples collected daily for 2 menstrual cycles will be measured in ug/dL by means of E1C immunoassay.

Pregnanediol-glucuronide (PDG) in urine samples collected daily for 2 menstrual cycles will be measured in ug/mL by means of PDG immunoassay.

Urinary Creatinine in urine samples collected daily for 2 menstrual cycles will be measured in mg/mL by means of spectrophotometric assay.

Participants will be provided with calendars on which to record detailed menstrual cycle information during the study. The total menstrual cycle length will be defined as the number of days from day 1 of menses to the day before the next menses. The Kassam method will be used to determine evidence of luteal activity, presumably ovulation. Follicular phase will be defined as the number of days from day 1 of menses up to the day of luteal transition and the luteal phase length will be defined as the number of days beginning from the day after the day of luteal transition to the day before the next menses.

University of Pennsylvania

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Premature Birth

Primary Ovarian Insufficiency

Menopause, Premature

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Menopause

Females ages 11-35 to be exposed to alkylating agent chemotherapy

Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.

A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment.

Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.

Ovarian Reserve After Cancer: Longitudinal Effects

Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium

Subjects are asked to document menstrual bleeding in a diary, noting duration of each menstrual period in days, bleeding intensity (spotting, light, moderate, heavy, flooding, none), and intervals between periods.

The validated "Menopausal Symptom List" (MSL) will be used at each study visit to assess the presence or absence of menopausal symptoms during the past month, the frequency and severity of each symptom. Symptoms captured include: hot flashes, vaginal dryness, concentration/memory problems, irritability, mood swings, feeling sad, feeling anxious, trouble sleeping, aches, joint pain, headaches.

Ovaries will be measured in three dimensions. Uterine size and endometrial thickness will also be performed. The transvaginal approach is preferred, but transabdominal ultrasound will be performed in girls who do not feel comfortable with the transvaginal procedure.

20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern.

All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and \>10 mm in diameter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
A Combination of Pazopanib and Carboplatin in Advanced Solid Malignancies	NCT01542047	Cancer, Metasta...	Carboplatin Pazopanib	18 Years -	New Mexico Cancer Care Alliance
Assessing Urinary Hormones in Female Cancer Survivors	NCT03197532	Effects of Chem...		20 Years - 50 Years	University of Pennsylvania
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer	NCT00970580	Non-Small Cell ...	BIIB022 With Pa...	18 Years -	Biogen
Ovarian Reserve After Cancer: Longitudinal Effects	NCT02467231	Effects of Chem... Premature Ovari...		11 Years - 35 Years	University of Pennsylvania

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