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Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer; Peritoneal Carcinoma; Tubal Carcinoma

Intervention: Iressa (ZD1839) (Drug); Arimidex (Anastrozole) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Carolyn Krasner, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.

Clinical Details

Official title: A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer

Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.

Secondary outcome:

To define the median time to progression of this patient population

to assess the tumor response and safety of this treatment.

Detailed description:

- Patients will receive Iressa and anastrozole orally once daily until treatment is ended.

Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression.

- Patients will be given a drug log in which to record the date and time they take their

pills, as well as any symptoms and concomitant medications.

- Patients will be seen monthly for the following tests and procedures; a physical

examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or

tubal carcinoma

- Asymptomatic from ovarian cancer

- Evidence of recurrent ovarian, peritoneal or tubal carcinoma

- Tumor sample must be positive for ER and/or PR

- 18 years of age or older

- ECOG performance status of less than or equal to 1

- Must be able to tolerate oral intake

Exclusion Criteria:

- Known hypersensitivity to Iressa or any of the excipients of this product

- Other coexisting malignancies or malignancies diagnosed within the last 5 years

- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital

or St. John's wort

- Treatment with a non-approved or investigational drug within 30 days

- Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer

therapy (except alopecia)

- Incomplete healing from previous oncologic or other major surgery

- Serum creatinine level greater than CTC grade 2

- Pregnant or breast feeding

- Severe uncontrolled systemic disease

- Significant clinical disorder or laboratory finding that makes it potentially unsafe

for the subject to participate

- Patients currently receiving other investigational antineoplastic agents, on systemic

chemotherapy or under radiation therapy treatment

- Patients previously treated with anastrozole or other aromatase inhibitor

- Unable to tolerate oral medications

- Clinical and/or radiographic evidence of current or impending bowel obstruction

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Additional Information

Starting date: October 2003
Ending date: March 2006
Last updated: December 28, 2007

Page last updated: June 20, 2008

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