Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Uterine Cervical Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genital Diseases, Female

Genital Neoplasms, Female

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Urogenital Neoplasms

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Genital Diseases

Peritoneal Diseases

Ovarian Diseases

Fallopian Tube Diseases

Endometrial Neoplasms

Endocrine Gland Neoplasms

Adnexal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Lenograstim

Tubulin Modulators

Antimitotic Agents

All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.

Filgrastim

Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly paclitaxel/carboplatin regimen in gynaecological cancers.

Purpose: This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma. Data obtained in this trial will be compared with historical data as published earlier.

The trial will include 3 cohorts of 36 patients:

* Subjects with ovarian, fallopian tube or peritoneal carcinoma
* Subjects with endometrial cancer
* Subjects with cervical carcinoma

Treatment:

Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2 years and then if clinically indicated. Subjects who develop disease progression will discontinue therapy. Subjects who have no evidence of disease progression after completion of study therapy will be followed until disease progression, withdrawal of informed consent, or death.

Primary objective:

- To evaluate the occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF

Secondary objectives:

* To evaluate per cohort the occurrence of grade 4 neutropenia
* To evaluate other toxicities
* To evaluate the dose reductions or dose delays in the chemotherapy
* To determine the progression free survival according to RECIST v1.1
* To evaluate the response rate and overall survival

Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers

Belgian Gynaecological Oncology Group

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Anti-Infective Agents

Trastuzumab

Pertuzumab

Trastuzumab deruxtecan

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Mitogens

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Immunoconjugates

doxorubicin and cyclophosphamide, followed by THP

Trastuzumab Deruxtecan

cyclophosphamide

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy.

Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).

Participants are assigned to one of three arms in parallel for the duration of the study.

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)

Qualified researchers can request access to anonymized individual patient data from AstraZeneca Group of Companies, sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ Disclosure Commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Proportion of participants who have no evidence by H\&E staining of residual invasive disease

Daiichi Sankyo

AstraZeneca

Symptoms and General Pathology

Infections

Immune System Diseases

Syndrome

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sarcoma

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

To determine response rate, median time to tumor progression, qualitative and quantitative toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions.

Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2 additional courses those who achieve partial response or stabilization, continue therapy until progression.

Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Baker Norton Pharmaceuticals

Colorectal Neoplasms

Intestinal Diseases

Colonic Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Herbal and Botanical

Fluorouracil

Irinotecan

Antimetabolites

Topoisomerase I Inhibitors

Cola

KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.

KRN330

Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Michael Kurman, MD

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Kyowa Hakko Kirin Pharma, Inc.

Kyowa Kirin Co., Ltd.

In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):

Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2

Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly

In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)

Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly

The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion

Phase 2: KRN330 Weekly + IRI Biweekly

KRN330 + Irinotecan

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Project Leader

In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).

Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly

Regimen A: KRN330 Biweekly + Irinotecan Biweekly

treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).

Regimen B: KRN330 Weekly + Irinotecan Biweekly

The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).

PH 2 Treatment: KRN330 Wkly + IRI Biwkly

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0

* Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)
* Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)

Phase 1 and 2Combined (N=65)

Overall Study

Micronutrients

Vitamins

Ascorbic Acid

Camptothecin

Trace Elements

Antioxidants

Protective Agents

Vitamin C

Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks

350mg/m2 irinotecan once a week every 3 weeks

Daniel A Monti, MD

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer

Thomas Jefferson University

The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks

Ascorbic Acid+Irinotecan

Standard of Care (Irinotecan Alone)

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.

Dr. Daniel Monti

The study was closed early due to lack of accrual. The data were not collected or analyzed.

Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Number of Participants That Are Alive After 11 Weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers	NCT01523678	Ovarian Cancer Endometrial Can... Uterine Cervica...	Filgrastim Paclitaxel Carboplatin	18 Years -	Belgian Gynaecological Oncology Group
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer	NCT05113251	Breast Neoplasm... Breast Cancer HER2-positive E...	Trastuzumab Der... Paclitaxel Trastuzumab Pertuzumab Doxorubicin cyclophosphamid...	18 Years -	AstraZeneca
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals	NCT00002189	Sarcoma, Kaposi HIV Infections	Paclitaxel	18 Years -	NIH AIDS Clinical Trials Information Service
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals	NCT00002189	Sarcoma, Kaposi HIV Infections	Paclitaxel	18 Years -	NIH AIDS Clinical Trials Information Service
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer	NCT00838578	Colorectal Canc...	KRN330 Irinotecan	18 Years -	Kyowa Kirin Co., Ltd.
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University

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