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A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer

Phase 1
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer


I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and
paclitaxel-resistant ovarian epithelial cancer.

II. Determine the qualitative and quantitative toxic effects of this regimen in these

III. Document the observed anti-tumor activity of this regimen in these patients.

IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this
regimen in these patients.

OUTLINE: This is a dose escalation study.

Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive
daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks.
Treatment is repeated every 21 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum
tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose
limiting toxicity.

Inclusion Criteria


- Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and
paclitaxel resistant as defined by: Disease progression while on first-line regimen
containing both a platinum drug and paclitaxel OR Tumor progression within 6 months
of completion of platinum-based therapy (either as first- or second-line) or
paclitaxel-based therapy (either as first- or second-line)

- Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any

- Nonmeasurable disease (with CA-125 at least 35)

- Ascites and/or pleural effusions allowed

- No borderline or low malignant potential tumors


- Age: 18 and over

- Performance status: Zubrod 0-2

- Life expectancy: At least 12 weeks

- WBC at least 3,000/mm3

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Bilirubin no greater than 1.5 mg/dL PT/PTT normal

- Creatinine no greater than 1.4 mg/dL

- No active, unresolved upper respiratory infections

- Not HIV positive

- At least 5 years since prior malignancy, except nonmelanomatous skin cancer

- Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity
for sampling of ascites or peritoneal fluid

- No concurrent serious medical illness

- No untreated gastrointestinal obstruction

- Not pregnant or nursing

- Fertile patients must use effective contraception


- May have failed an unlimited number of prior chemotherapy regimens

- At least 30 days since prior chemotherapy

- No prior radiotherapy to the pelvis or abdomen

- Eligible for laparoscopy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Judith K. Wolf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009