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Phase 2 N=27 Treatment

Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer

Cervical Cancer

Enrolled (actual)
27
Serious AEs
36.0%
Results posted
Jan 2019
Primary outcome: Primary: Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 0; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
topotecan hydrochloride (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Gynecologic Oncology Group
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
0; 0
PRIMARY
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
6; 4; 9; 5; 1; 16

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the cervix
  • Squamous cell or nonsquamous cell
  • Persistent or recurrent disease
  • Documented disease progression
  • Measurable disease
  • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy
  • Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix
  • Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Sensory or motor neuropathy ≤ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
  • Monoclonal antibodies
  • Cytokines
  • Small-molecule inhibitors of signal transduction
  • At least 3 weeks since prior biologic or immunologic agents for cervical cancer
  • No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
  • No concurrent prophylactic thrombopoietic agents

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
  • No prior topotecan

Endocrine therapy

  • At least 1 week since prior hormonal therapy for cervical cancer
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for cervical cancer
  • No prior cancer therapy that would preclude study participation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00087126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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