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A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in
patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer,
or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen
in these patients. III. Determine the duration of objective response, time to tumor
progression, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced ovarian
epithelial cancer, fallopian tube cancer, or primary peritoneal cancer Serous papillary
Endometrioid Mucinous Clear cell Poorly differentiated adenocarcinomas Mixture of any of
the above histologies No sarcomatous, stromal, or germ cell elements Measurable disease by
radiological imaging with progression in the past 3 months or no response to prior therapy
The following are not considered measurable: Pleural effusions Ascites Osseous metastases
CA-125 tumor markers Lesions in previously irradiated areas Platinum resistant or
refractory Less than 6 month treatment-free interval after platinum-containing regimen OR
Progression during platinum-based therapy No leptomeningeal or carcinomatous meningitis
Known CNS metastases allowed if patient is previously treated, neurologically stable, has
no evidence of active disease by CT or MRI, and has no requirement for therapy with oral
or IV steroids or anticonvulsants

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.5
mg/dL ALT and AST no greater than 3.0 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No gross hematuria
Cardiovascular: No uncontrolled cardiac arrhythmia No myocardial infarction within the
past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception during and for at least 6 months after study No unstable
medical conditions No severe concurrent disease or infection that would preclude study No
intestinal obstruction interfering with nutrition No psychiatric disorders that would
preclude study No other prior malignancy within the past 5 years except adequately treated
carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered At least 2 weeks since prior prophylactic filgrastim (G-CSF) or sargramostim
(GM-CSF) No concurrent immunotherapy No concurrent biological response modifiers
Chemotherapy: See Disease Characteristics At least 1 but no more than 3 prior chemotherapy
regimens (platinum-containing regimens count as 1 regimen) At least 4 weeks since prior
chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks
since prior radiotherapy or radiopharmaceuticals and recovered No prior radiotherapy to
whole pelvis No concurrent radiotherapy including palliative radiotherapy (except local
radiotherapy for pain or solitary brain metastasis if not progressing systemically)
Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days
since prior investigational drugs No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Safety Issue:


Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

December 2009

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Memorial Sloan-Kettering Cancer Center New York, New York  10021