Weiss 1992.
Methods | Randomised Phase II | |
Participants | 44 women with persistent, recurrent or metastatic Squamous cell cancer cervix 1987 to 1990 |
|
Interventions | Arm 1: didemnin B 2.6‐3.5 mg/m2 iv over 30 minutes d1 q28 (subsequent dose escalations if no toxicity) Arm 2: trimetrexate 8 mg/m2 if previous radiotherapy or 12 mg/m2 if no radiotherapy iv over 10 minutes d1‐5 q21 (dose escalations to 15 mg/m2 and 18 mg/m2 respectively permitted on subsequent cycles if no toxicity) |
|
Outcomes | Overall response rate | |
Notes | 0% response rate in either arm at any dose 1 patient ineligible as baseline imaging not done within 14 days of starting treatment |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not documented |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | High risk | Not documented |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |
d: day; h: hour; GOG: Gynecologic Oncology Group; im: intramuscular; ITT: intention to treat; iv: intravenous; OS: overall survival; po: orally; QoL: quality of life; SWOG: Southwest Oncology Group; MVAC: methotrexate/vinblastine/doxorubicin/cisplatin; WHO: World Health Organization.