Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed no age specified NCI AECM-1199508304 NCI-T95-0063H, T95-0063

Objectives

I.  Evaluate the objective response rate, duration of response, and survival 
in women with advanced, locally advanced, inoperable, or recurrent carcinoma 
of the cervix to 9-cis-retinoic acid (9-CRA).

II.  Characterize the toxic effects of systemic 9-CRA.

Entry Criteria

Disease Characteristics:

Histologically proven squamous cell or adenosquamous cell carcinoma of the
uterine cervix incurable by or recurrent after radiotherapy or surgery, i.e.:
  Disease outside the pelvis, including lung, liver, lymph node, skin, or
     retroperitoneal metastases
  Positive para-aortic lymph nodes
  Recurrent disease outside prior radiotherapy field
  Bulky FIGO Stage IIIb disease to both pelvic sidewalls

Bulky Stage Ib or II disease eligible for surgery or radiotherapy may receive
protocol treatment as neoadjuvant therapy

Disease bidimensionally measurable

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy preferred (1 prior regimen allowed)
  No prior retinoic acid
  At least 4 weeks since chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  At least 2 weeks since surgery and on normal diet

Patient Characteristics:

Age:
  Any age

Performance status:
  ECOG 0 or 1

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 3 x ULN
  SGOT no greater than 3 x ULN
  No hyperlipidemia

Renal:
  Creatinine no greater than 2.0 mg/dL

Cardiovascular:
  No NYHA class III/IV status
  No uncontrolled CHF
  No angina

Pulmonary:
  No chronic obstructive pulmonary disease

Other:
  No active infection
  No AIDS, ARC, or HIV antibody
  No requirement for steroids
  No concurrent systemic or topical retinoids, including:
     Beta carotene compounds
     High-dose vitamin A, i.e., more than 15,000 IU/day
  No substance abuse or psychiatric condition that would preclude therapy
  No prior invasive malignancy except resected nonmelanomatous skin cancer
  No pregnant or nursing women
     Negative serum beta-HCG required of fertile women within 7 days prior to
     protocol therapy
  Effective contraception required of fertile women

Expected Enrollment

If at least 1 response is observed in the first 13 patients in either prior 
chemotherapy stratum, 14 additional patients will be entered in that stratum.

Outline

Single-Agent Chemotherapy.  9-cis-retinoic acid, 9-CRA, NSC-659772.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Scott Wadler, MD, Protocol chair(Contact information may not be current)		Ph: 718-904-2754