Overview

Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer

Status:
Completed
Trial end date:
2020-11-04
Target enrollment:
0
Participant gender:
Female
Summary
The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growth factor receptor (EGF-R) positive (>/= 1+). 2. To determine the response rate and response duration in this patient population treated with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in combination with standard dose gefitinib, given by way of the mouth (PO) daily.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
AstraZeneca
GlaxoSmithKline
Treatments:
Gefitinib
Topotecan
Criteria
Inclusion Criteria:

- Women with platinum-resistant, histologically confirmed epithelial ovarian, fallopian
tube or peritoneal cancer. Resistance is defined as: Progression of disease during
platinum chemotherapy, or progression of disease within 6 months of completing
platinum chemotherapy, or failure to achieve a complete response, with persistent
macroscopic disease, after an adequate trial of primary therapy.

- EGF-R expression must be positive (e.g., 1+ or greater) See appendix G.

- Patients with a known hypersensitivity to platinum compounds, who have failed a
desensitization regimen, or in the opinion of the investigator, are not good
candidates for desensitization, are eligible.

- Patients must have measurable disease.

- Unlimited number of prior chemotherapy regimens are allowed.

- Zubrod performance status
- Patients must have adequate hepatic, renal, and bone marrow function, defined as serum
creatinine /=2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) white blood count (WBC) >/= 3,000/mm3; absolute neutrophil count (ANC) >/= 1,500/mm3;
platelets >/= 100,000/mm3.

- At least three weeks must have elapsed from completion of chemotherapy or radiation
therapy.

- At least 30 days must have elapsed from completion of treatment with a non-approved or
investigational drug.

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study, in keeping with the policies of the hospital. The
only approved consent is appended to this protocol.

- Women of childbearing potential must be willing to practice acceptable methods of
birth control to prevent pregnancy.

Exclusion Criteria:

- Patients with borderline or low malignant potential tumors are not eligible.

- Patients who have had prior therapy with topoisomerase I inhibitors.

- Patients who are pregnant or lactating.

- Concurrent chemotherapy, radiation therapy, or surgery (excluding palliative
radiation).

- Concurrent, uncontrolled, medical or psychiatric disorders.

- Patients with an active infection.

- Patients with a known hypersensitivity to topotecan or iressa.

- Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic
treatment or congestive heart failure) (NYHA classification III or IV).

- History of other malignancy (except nonmelanoma skin cancer or carcinoma in situ of
the cervix), unless in complete remission and off all therapy for that disease for a
minimum of 5 years.

- Patients with overt psychosis or mental disability or otherwise incompetent to give
informed consent.

- Patients who have had prior anti-EGFR therapy (i.e. Tarceva, Cetuximab).

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the trial.

- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's
Wort.

- Any evidence of clinically active interstitial lung disease (patient with chronic
stable radiographic changes who are asymptomatic are eligible).