Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Adenocarcinoma

Recurrence

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.

John Farley, MD

Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix will receive Pemetrexed.

Patients will receive Pemetrexed 500 mg/m2 every three week.

On initiation of pemetrexed, on day one of first chemotherapy cycle, patients will begin taking folic acid at a dose of 350 to 600 mcg daily as well as receive an intramuscular injection of 1000 mcg of vitamin B12, with subsequent vitamin B12 injections given every 9 weeks while on study.

A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.

Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.

Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.

Western Regional Medical Center

Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.

Pemetrexed: Pemetrexed 500 mg/m2

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Jessica L. Coats

Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.

Progression Free Survival

Response Rate

Overall Survival

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Topotecan

Topoisomerase I Inhibitors

Pazopanib 600 mg taken orally continuously while Topotecan 0.25 mg taken orally for 21 days continuously followed by 7 days off. A cycle will be defined as 28 days.

During follow up if disease gets worse, participant called by study staff every 3 months.

Pazopanib

0.25 mg by mouth daily for 21 days of a 28 day cycle.

During follow up if disease gets worse, participant called by study staff every 3 months. Each call should last about 5 minutes.

Phone Call

Michael M. Frumovitz, MD, MPH

The goal of this clinical research study is to learn if the combination of topotecan and pazopanib can help to control recurrent cervical cancer. The safety of the study drug combination will also be studied.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drugs in 28-day study cycles.

You will take pazopanib every day for 28 days. You will take topotecan at about the same time every day on Days 1-21, but not take it on Days 22-28.

You should not take pazopanib 1 hour before or within 2 hours after eating. The pazopanib tablets should be swallowed whole with about a cup (8 ounces) of water.

You should not chew, crush, dissolve, or divide either the topotecan or the pazopanib tablets.

You will be given a study drug diary in which you will write information about when you take the study drug each time and how much you took. You will bring this diary to every study visit.

Study Visits:

On Day 1 of each cycle:

* You will have a physical exam. This will include a pelvic exam every 2 cycles.
* Blood (about 2 tablespoons) and urine will be collected for routine tests.
* Blood (about 2 tablespoons) will be collected for biomarker testing (Cycles 1 and 2 only), including genetic biomarkers. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.
* If you can become pregnant, you will have a urine pregnancy test.

If you are taking warfarin, blood (about 2 tablespoons) will be drawn to check your blood's ability to clot. This will be done weekly during Cycle 1 and on any cycle after which you change your dose of warfarin or one of the study drugs.

On Day 1 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have a CT scan or MRI of your abdomen and pelvis to check the status of the disease. You will also have an x-ray or CT scan of the chest to check the status of the disease as needed.

If the disease appears to be getting better at any time while you are taking the study drug, blood (about 2 tablespoons) will be drawn for biomarker testing.

If the study doctor thinks you are responding to the study drugs, blood (about 2 tablespoons) will be drawn on Day 1 of Cycle 6. If you leave the study before then, this sample will be drawn at that time.

End-of-Study Visit:

Within 4 weeks after your last dose of study drugs:

* You will have a physical exam.
* Blood (about 2 ½ teaspoons) will be drawn for routine tests.
* You will have a chest x-ray and either a CT scan or an MRI to check the status of disease.

If you are taking warfarin, blood (about 2 tablespoons) will be drawn to check your blood's ability to clot.

° If you stopped taking the study drug before Cycle 6 because the disease got worse, blood (about 2 tablespoons) will be drawn for biomarker testing.

Follow-Up Visits:

If you came off study for a reason other than the disease getting worse, you will be asked to return to the clinic for follow-up testing every 3 months. At these visits:

* You will have a physical exam.
* If the study doctor thinks it is needed, you will have a CT scan, MRI, or x-ray to check the status of the disease.

If the disease did get worse, you will be called every 3 months and asked about how you are doing. Each call should last about 5 minutes.

This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of advanced kidney cancer and certain types of advanced soft tissue sarcoma such as bone, cartilage, fat, or muscle. Topotecan is FDA approved and commercially available for the treatment of metastatic ovarian cancer that has returned after treatment and for the treatment of small cell lung cancer that has returned after first-line treatment. Topotecan is also FDA approved to treat advanced, recurrent or persistent carcinoma of the cervix in combination with cisplatin. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work.

Up to 40 participants will be enrolled in this multicenter study. Up to 30 will take part at MD Anderson. Up to 10 will be enrolled at the Harris Health System.

Phase II Study of Pazopanib and Topotecan in Cervical Cancer

A Phase II Study of Pazopanib and Oral Topotecan in Women With Recurrent Cervical Cancer

Duration of overall response measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Duration of overall CR is measured from the time measurement criteria are first met for CR until first date that recurrent disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Any pathologic lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

GlaxoSmithKline

M.D. Anderson Cancer Center

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.

CIGB300

They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.

Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation

Laboratorio Elea Phoenix S.A.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas	NCT02868892	Adenocarcinoma ... Adenosquamous C...	Pemetrexed	18 Years -	Western Regional Medical Center
Phase II Study of Pazopanib and Topotecan in Cervical Cancer	NCT02348398	Cervical Cancer	Pazopanib Topotecan Phone Call	18 Years -	M.D. Anderson Cancer Center
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application	NCT01639625	Squamous Cell C... Adenocarcinoma ...	CIGB300	21 Years - 70 Years	Laboratorio Elea Phoenix S.A.
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application	NCT01639625	Squamous Cell C... Adenocarcinoma ...	CIGB300	21 Years - 70 Years	Laboratorio Elea Phoenix S.A.

Spots Global Cancer Trial Database for adenocarcinoma of the cervix