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Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

Sponsored by Herbert Irving Comprehensive Cancer Center

About this trial

Last updated 11 years ago

Study ID

CDR0000065736

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 60 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 21 years ago

What is this trial about?

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 II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

What are the Participation Requirements?

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent, persistent or metastatic cervical carcinoma
(squamous or adenocarcinoma), with no potentially curative standard treatment

- Measurable disease or evaluable disease

PATIENT CHARACTERISTICS:

Age:

- 18 to physiological 60

Performance status:

- ECOG 0-2

Life expectancy:

- Greater than 2 months

Hematopoietic:

- WBC greater than 3000/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

- Bilirubin less than 1.5 times normal

- SGOT/SGPT less than 1.5 times normal

Renal:

- BUN less than 1.5 times normal

- Creatinine less than 1.5 times normal

- Creatinine clearance greater than 50 mL/min

Other:

- Ineligible for other high priority national or institutional study

- Not pregnant or nursing

- HIV negative

- No prior malignancy except nonmelanoma skin cancer

- No serious medical or psychiatric illness preventing treatment or informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Greater than 4 weeks since prior chemotherapy

- No greater than 2 prior chemotherapy regimens

- No prior taxane or camptothecin

Endocrine therapy:

- No concurrent hormonal therapy except that required for nondisease related conditions
(e.g., insulin for diabetes)

Radiotherapy:

- Greater than 4 weeks since prior radiation therapy

- No concurrent radiation therapy

Surgery:

- Greater than 4 weeks since prior surgery

Locations

Location

Status