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Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

NCT00003382TerminatedPHASE1INTERVENTIONAL

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.

Key Facts

Lead Sponsor

Gynecologic Oncology Group

Start Date

1998-05-01

Completion Date

2006-04-01

Study Type

INTERVENTIONAL

Official Title

A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

Interventions

filgrastimgemcitabine hydrochloridetopotecan hydrochloride

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

DISEASE CHARACTERISTICS:

* Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer
* No borderline ovarian cancer
* Extra-ovarian papillary serous tumors eligible
* Must not be eligible for any higher priority phase II or III GOG protocol

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* SGOT no greater than 3 times upper limit of normal (ULN)
* Bilirubin no greater than 1.5 mg/dL
* Elevated levels of alkaline phosphatase allowed

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias
* No uncontrolled hypertension

Other:

* No other active malignancy
* No prior malignancy within the past 5 years except nonmelanomatous skin cancer
* No active infection
* No underlying medical problem that would prevent compliance
* No known hypersensitivity to E. coli-derived drug preparations
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Must have received at least 1 prior platinum- and paclitaxel-based regimen
* At least 4 weeks since prior chemotherapy
* No prior topotecan and/or gemcitabine
* No prior chemotherapy for a different prior malignancy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to more than 10% of bone marrow
* At least 2 weeks since limited field radiation therapy

Surgery:

* Not specified

Locations

Community Hospital of Los Gatos, Los Gatos, United States

Chao Family Comprehensive Cancer Center, Orange, United States

Women's Cancer Center, Palo Alto, United States

University of Chicago Cancer Research Center, Chicago, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, United States

University of Pennsylvania Cancer Center, Philadelphia, United States