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

PF-07260437

B7-H4 IHC

Pfizer CT.gov Call Center

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN ADVANCED OR METASTATIC SOLID TUMORS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

DLTs will be evaluated in Part 1. The number of DLTs will be used to determine the dose escalation decision and recommended dose of PF-07260437

DOR as assessed using RECIST 1.1 and irRECIST

TTP as assessed using RECIST 1.1 and irRECIST

ORR as assessed using RECIST 1.1 and irRECIST

PFS as assessed using RECIST 1.1 and irRECIST

Immune Cells assessments from paired biopsies

Pfizer

Symptoms and General Pathology

Recurrence

Male Urogenital Diseases

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

900 mg/m2, intravenous (IV), every 21 days, until disease progression

pemetrexed

David Miller, MD

The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.

Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.

Gynecologic Oncology Group

Eli Lilly and Company

Chief Medical Officer

40-49 years

50-59 years

60-69 years

>69 years

Age, Customized

Sex: Female, Male

White

Black

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

G1 - Well-Differentiated

G2 - Moderately Differentiated

G3 - Poorly Differentiated

Assesses the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type. Grades range from 1 (least aggressive and best prognosis) to 4 (most aggressive and worst prognosis).

Grade (Histology)

0 - Fully active

1 - Ambulatory, Restricted Strenuous Activity

Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Gynecologic Oncology Group (GOG) Performance Status

Prior Chemotherapy

No Prior Chemotherapy

Prior Radiotherapy

No Prior Radiotherapy

Participants could have more than one type of prior treatment (radiotherapy and/or chemotherapy).

Prior Treatment

Completed Response

Partial Response

Stable Disease

Progressive Disease

Inevaluable

Tumor Response

Leukopenia - Grade 1

Leukopenia - Grade 2

Leukopenia - Grade 3

Leukopenia - Grade 4

Thrombocytopenia - Grade 1

Thrombocytopenia - Grade 2

Thrombocytopenia - Grade 3

Thrombocytopenia - Grade 4

Neutropenia - Grade 1

Neutropenia - Grade 2

Neutropenia - Grade 3

Neutropenia - Grade 4

Anemia - Grade 1

Anemia - Grade 2

Anemia - Grade 3

Anemia - Grade 4

Coagulation - Grade 1

Coagulation - Grade 2

Coagulation - Grade 3

Coagulation - Grade 4

Nausea/vomiting - Grade 1

Nausea/vomiting - Grade 2

Nausea/vomiting - Grade 3

Nausea/vomiting - Grade 4

Gastrointestinal - Grade 1

Gastrointestinal - Grade 2

Gastrointestinal - Grade 3

Gastrointestinal - Grade 4

Alopecia - Grade 1

Alopecia - Grade 2

Dermatologic - Grade 1

Dermatologic - Grade 2

Dermatologic - Grade 3

Dermatologic - Grade 4

Alkaline phosphatase - Grade 1

Alkaline phosphatase - Grade 2

Alkaline phosphatase - Grade 3

Alkaline phosphatase - Grade 4

Serum glutamic-oxaloacetic transaminase - Grade 1

Serum glutamic-oxaloacetic transaminase - Grade 2

Serum glutamic-oxaloacetic transaminase - Grade 3

Serum glutamic-oxaloacetic transaminase - Grade 4

Neurologic - Grade 1

Neurologic - Grade 2

Neurologic - Grade 3

Neurologic - Grade 4

Infection - Grade 1

Infection - Grade 2

Infection - Grade 3

Infection - Grade 4

Pulmonary - Grade 1

Pulmonary - Grade 2

Pulmonary - Grade 3

Pulmonary - Grade 4

Metabolic - Grade 1

Metabolic - Grade 2

Metabolic - Grade 3

Metabolic - Grade 4

Lymphatics - Grade 1

Lymphatics - Grade 2

Lymphatics - Grade 3

Lymphatics - Grade 4

Pain - Grade 1

Pain - Grade 2

Pain - Grade 3

Pain - Grade 4

Constitutional - Grade 1

Constitutional - Grade 2

Constitutional - Grade 3

Constitutional - Grade 4

Renal - Grade 1

Renal - Grade 2

Renal - Grade 3

Renal - Grade 4

Musculoskeletal - Grade 1

Musculoskeletal - Grade 2

Number of Participants With Adverse Events by Grade (Measures of Toxicity)

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
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors	NCT05067972	Ovarian Neoplas... Endometrial Neo... Breast Neoplasm...	PF-07260437 B7-H4 IHC	18 Years -	Pfizer
A Trial for Patients With Advanced/Recurrent Endometrial Cancer	NCT00377520	Neoplasms Neoplasms by Si... Urogenital Neop... Genital Neoplas... Uterine Neoplas... Endometrial Neo... Cancer of Endom... Endometrial Can... Cancer of the E... Endometrium Can... Neoplasms, Endo...	pemetrexed	-	Eli Lilly and Company
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery	NCT01562106	Endometrial Can...	Fluorescence-gu...	18 Years -	Swedish Medical Center
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery	NCT01562106	Endometrial Can...	Fluorescence-gu...	18 Years -	Swedish Medical Center
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors	NCT05067972	Ovarian Neoplas... Endometrial Neo... Breast Neoplasm...	PF-07260437 B7-H4 IHC	18 Years -	Pfizer
Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer	NCT00267488	Neoplasms, Endo... Endometrial Can...	topotecan	18 Years -	GlaxoSmithKline
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer	NCT04269200	Endometrial Neo...	olaparib durvalumab durvalumab plac... olaparib placeb... Carboplatin Paclitaxel	18 Years - 150 Years	AstraZeneca

Spots Global Cancer Trial Database for neoplasms, endometrial